Regulatory Intelligence and Policy Lead

Astellas Pharma US, Inc., a U. S. affiliate of Tokyo-based Astellas Pharma Inc., is a pharmaceutical company dedicated to changing tomorrow by improving the health of people around the world through innovative and reliable pharmaceutical products. In 2005, Astellas was formed by blending the talents, resources and passions of two highly successful firms - Yamanouchi and Fujisawa. Astellas aims to maintain and strengthen our position as the global leader in transplantation and urology areas, and going forward we are working to establish our position as a global category leader in oncology. At all levels throughout the company our people are committed to the opportunity to positively affect and improve patient lives while remaining socially responsible to our community and those with whom we work and collaborate. For more information about Astellas Pharma US, Inc., please visit our Web site at www.astellas.us.

Astellas Pharma Inc. is seeking a Regulatory Intelligence and Policy Lead, Director for the UK and Ireland. The role involves leading the identification, interpretation, and communication of global CMC regulatory intelligence and emerging trends, guiding decision-making across development, manufacturing, quality, and regulatory functions. The position requires monitoring worldwide regulations, developing strategic research roadmaps, translating complex regulatory changes into guidance, representing Astellas in industry groups, building relationships with regulatory authorities, advising senior leadership, and anticipating regulatory changes to ensure compliance and strategic planning. The role offers a hybrid working model, balancing home-based work with in-office days, and involves collaboration with global teams and external stakeholders.

United Kingdom

Astellas Pharma Inc. is seeking a Regulatory Intelligence and Policy Lead, Director for the UK and Ireland. The role involves leading the identification, interpretation, and communication of global CMC regulatory intelligence and emerging trends, guiding decision-making across development, manufacturing, quality, and regulatory functions. The position requires monitoring worldwide regulations, developing strategic research roadmaps, translating complex regulatory changes into guidance, representing Astellas in industry groups, building relationships with regulatory authorities, advising senior leadership, and anticipating regulatory changes to ensure compliance and strategic planning. The role offers a hybrid working model, balancing home-based work with in-office days, and involves collaboration with global teams and external stakeholders.Benefits:<ul><li> Hybrid working environment allowing flexibility between home and office.</li><li> Opportunities to work with industry working groups and regulatory authorities.</li><li> Supportive environment for professional development in regulatory affairs.</li></ul>

Astellas Pharma US

Regulatory Intelligence and Policy Lead Astellas Pharma Inc. is seeking a Regulatory Intelligence and Policy Lead, Director for the UK and Ireland. The role involves leading the identification, interpretation, and communication of global CMC regulatory intelligence and emerging trends, guiding decision-making across development, manufacturing, quality, and regulatory functions. The position requires monitoring worldwide regulations, developing strategic research roadmaps, translating complex regulatory changes into guidance, representing Astellas in industry groups, building relationships with regulatory authorities, advising senior leadership, and anticipating regulatory changes to ensure compliance and strategic planning. The role offers a hybrid working model, balancing home-based work with in-office days, and involves collaboration with global teams and external stakeholders. Regulatory Intelligence and Policy Lead Operations Astellas Pharma US pharmaceuticals antiinfectives biotechnology cardiology cns creativity customer dermatology discovery fitness health health-care hospital immunology infectious-disease medical nephrology oncology pain pain-management pharmaceutical-manufacturing randd rd transplant urology wellness

Astellas Pharma Inc. is hiring a Regulatory Intelligence and Policy Lead, Director for the UK and Ireland to guide global regulatory strategies. The role involves monitoring regulations, developing strategic insights, and representing the company in industry dialogues, with a hybrid work model and opportunities for collaboration with external stakeholders.

Vice President, Corporate Quality

Celgene Corporation is a global biopharmaceutical company focused on the discovery, development, and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases. Founded in 1986, Celgene has been a leader in developing therapies that improve patient outcomes and quality of life. The company is known for its strong pipeline of novel drugs and commitment to scientific innovation. Celgene operates worldwide and is dedicated to advancing medical science through cutting-edge research and collaboration.

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary This global executive role shapes and drives the Corporate Quality vision, delivering strategic leadership and enterprise-wide quality and compliance across Bristol Myers Squibb. As a trusted advisor to senior leadership, the VP ensures alignment with business goals and global regulations, proactively managing quality risks and opportunities. The VP owns the global Quality Management System (QMS), championing its effectiveness and continuous improvement throughout the product lifecycle—from R&D to commercialization. Responsibilities include leading Quality Governance, setting enterprise KPIs, and overseeing SOPs, training, and digital quality systems (including GxP AI governance). With a forward-looking approach, this leader engages regulators and industry peers, anticipates emerging requirements, and ensures BMS remains inspection-ready and compliant. The role provides expert oversight for internal operations and external partners, guiding remediation and regulatory communications. Reporting directly to the Chief Quality Officer (CQO), this position is a key member of the Global Quality Leadership Team. Key Responsibilities Establishes and oversees a unified, process-centric Quality Management System (QMS) that spans the entire product lifecycle, ensuring continuous improvement, fit-for-purpose solutions, and simplification. Lead the development, implementation, and ongoing effectiveness of the global QMS in alignment with regulatory expectations across all enterprise functions. Drive Enterprise Quality Governance by setting quality metrics and KPIs to monitor performance and sustain improvement. Builds and develops a cross-divisional Global Process Owner Network that will develop and sustain the QMS working collaboratively with senior leaders across R&D, GPDS and Commercial. Oversees SOP governance, document control, training programs, data integrity and electronic quality systems (including AI governance). Designs and implements internal processes and communication mechanisms to assess emerging global regulatory expectations for impact on the organization and the overall BMS quality management system, to ensure ongoing compliance. Ensure these processes are linked to the broader regulatory policy forums in BMS at the enterprise level. working groups, etc. representing BMS strategic initiatives and input. Communicates effectively and builds cooperative and supportive working relationships across the Divisions and with external partners on quality, compliance and regulatory matter. Interfaces with members of the Divisional Leadership teams and the Quality Leadership Team. Engages and presents to BMS Leadership Team, CEO and BoD Board of Directors at the request and direction of CQO. Oversees and leads quality and compliance risk management initiatives to minimize risk and potential impact of quality and/or non-compliance events to the company. Builds and deploys Culture of Excellence plans to improve a culture of Quality across BMS. Ensures proactive quality and compliance oversight and adherence to QMS across internal operations and external partners through risk-based approaches, global inspection readiness, and independent audit. Provides quality and compliance expertise and oversight in support of significant compliance remediation, Health Authority inspection responses and actions, and regulatory communications including FARs, BPDRs, DPRs, etc. Actively engages with regulators and industry peers, representing BMS across industry and regulatory QMS forums to drive/leverage best practices, shares knowledge and industry/regulatory trends designed to continuously improve the QMS at BMS. Chairs the QMS Governance Forum responsible for overseeing the QMS operating model. Builds and continuously develops a high-performing global Quality team. Fosters a culture of accountability, integrity, collaboration, and innovation within Quality and across the Enterprise. Qualifications & Experience Minimum of 20+ years of BioPharma experience, with demonstrated experience in R&D and commercial manufacturing including pharmaceutical and biologics experience. Bachelor of Science in relevant Science (e.g. Chemistry, Biology, Chemical Engineering) or Engineering disciplines; and advanced degree (MBA, MS or PhD) preferred Extensive knowledge and experience in GxP global regulations necessary for appropriate decision making and representing BMS to regulatory agencies. Experience in leading a major quality discipline with GxP quality experience. Extensive experience in GLPs, GCPs, GPVP and GMPs (inclusive of medical devices). International regulatory experience in GxP environment. Previous proven experience dealing with FDA and other major regulatory agencies. Experience with digital innovation, including automation and Artificial Intelligence capabilities. Managed a large global operation involving diverse cultures and employees. Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management. In-depth experience in managing large teams, and in providing coaching, development and mentoring to employees. Experienced in advanced technology including technology transfer, e.g., R&D to manufacturing and/or between operations. Experience with managing a large budget. Experience in Computer System Validation, Analytical Methods development/transfer, Quality Systems, Product Quality complaint, combination Products/Device Quality. Position may require 20-30% travel on occasion. #LI-HYBRID If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: $373,380 - $452,448 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

This executive role leads the global corporate quality vision, ensuring compliance and continuous improvement across Bristol Myers Squibb.

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary This global executive role shapes and drives the Corporate Quality vision, delivering strategic leadership and enterprise-wide quality and compliance across Bristol Myers Squibb. As a trusted advisor to senior leadership, the VP ensures alignment with business goals and global regulations, proactively managing quality risks and opportunities. The VP owns the global Quality Management System (QMS), championing its effectiveness and continuous improvement throughout the product lifecycle—from R&D to commercialization. Responsibilities include leading Quality Governance, setting enterprise KPIs, and overseeing SOPs, training, and digital quality systems (including GxP AI governance). With a forward-looking approach, this leader engages regulators and industry peers, anticipates emerging requirements, and ensures BMS remains inspection-ready and compliant. The role provides expert oversight for internal operations and external partners, guiding remediation and regulatory communications. Reporting directly to the Chief Quality Officer (CQO), this position is a key member of the Global Quality Leadership Team. Key Responsibilities Establishes and oversees a unified, process-centric Quality Management System (QMS) that spans the entire product lifecycle, ensuring continuous improvement, fit-for-purpose solutions, and simplification. Lead the development, implementation, and ongoing effectiveness of the global QMS in alignment with regulatory expectations across all enterprise functions. Drive Enterprise Quality Governance by setting quality metrics and KPIs to monitor performance and sustain improvement. Builds and develops a cross-divisional Global Process Owner Network that will develop and sustain the QMS working collaboratively with senior leaders across R&D, GPDS and Commercial. Oversees SOP governance, document control, training programs, data integrity and electronic quality systems (including AI governance). Designs and implements internal processes and communication mechanisms to assess emerging global regulatory expectations for impact on the organization and the overall BMS quality management system, to ensure ongoing compliance. Ensure these processes are linked to the broader regulatory policy forums in BMS at the enterprise level. working groups, etc. representing BMS strategic initiatives and input. Communicates effectively and builds cooperative and supportive working relationships across the Divisions and with external partners on quality, compliance and regulatory matter. Interfaces with members of the Divisional Leadership teams and the Quality Leadership Team. Engages and presents to BMS Leadership Team, CEO and BoD Board of Directors at the request and direction of CQO. Oversees and leads quality and compliance risk management initiatives to minimize risk and potential impact of quality and/or non-compliance events to the company. Builds and deploys Culture of Excellence plans to improve a culture of Quality across BMS. Ensures proactive quality and compliance oversight and adherence to QMS across internal operations and external partners through risk-based approaches, global inspection readiness, and independent audit. Provides quality and compliance expertise and oversight in support of significant compliance remediation, Health Authority inspection responses and actions, and regulatory communications including FARs, BPDRs, DPRs, etc. Actively engages with regulators and industry peers, representing BMS across industry and regulatory QMS forums to drive/leverage best practices, shares knowledge and industry/regulatory trends designed to continuously improve the QMS at BMS. Chairs the QMS Governance Forum responsible for overseeing the QMS operating model. Builds and continuously develops a high-performing global Quality team. Fosters a culture of accountability, integrity, collaboration, and innovation within Quality and across the Enterprise. Qualifications & Experience Minimum of 20+ years of BioPharma experience, with demonstrated experience in R&D and commercial manufacturing including pharmaceutical and biologics experience. Bachelor of Science in relevant Science (e.g. Chemistry, Biology, Chemical Engineering) or Engineering disciplines; and advanced degree (MBA, MS or PhD) preferred Extensive knowledge and experience in GxP global regulations necessary for appropriate decision making and representing BMS to regulatory agencies. Experience in leading a major quality discipline with GxP quality experience. Extensive experience in GLPs, GCPs, GPVP and GMPs (inclusive of medical devices). International regulatory experience in GxP environment. Previous proven experience dealing with FDA and other major regulatory agencies. Experience with digital innovation, including automation and Artificial Intelligence capabilities. Managed a large global operation involving diverse cultures and employees. Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management. In-depth experience in managing large teams, and in providing coaching, development and mentoring to employees. Experienced in advanced technology including technology transfer, e.g., R&D to manufacturing and/or between operations. Experience with managing a large budget. Experience in Computer System Validation, Analytical Methods development/transfer, Quality Systems, Product Quality complaint, combination Products/Device Quality. Position may require 20-30% travel on occasion. #LI-HYBRID If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: $373,380 - $452,448 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.Benefits:<ul><li> Wide variety of competitive benefits, services and programs that provide resources to pursue personal and professional goals.</li><li> Health Coverage: Medical, pharmacy, dental, and vision care.</li><li> Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).</li><li> Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.</li><li> Work-life benefits including flexible time off (unlimited, with manager approval), 11 paid national holidays, 160 hours annual paid vacation, and optional holidays.</li><li> Additional time off for eligible employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Years Day.</li></ul>

Celgene Corporation

Vice President, Corporate Quality This executive role leads the global corporate quality vision, ensuring compliance and continuous improvement across Bristol Myers Squibb. Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary This global executive role shapes and drives the Corporate Quality vision, delivering strategic leadership and enterprise-wide quality and compliance across Bristol Myers Squibb. As a trusted advisor to senior leadership, the VP ensures alignment with business goals and global regulations, proactively managing quality risks and opportunities. The VP owns the global Quality Management System (QMS), championing its effectiveness and continuous improvement throughout the product lifecycle—from R&D to commercialization. Responsibilities include leading Quality Governance, setting enterprise KPIs, and overseeing SOPs, training, and digital quality systems (including GxP AI governance). With a forward-looking approach, this leader engages regulators and industry peers, anticipates emerging requirements, and ensures BMS remains inspection-ready and compliant. The role provides expert oversight for internal operations and external partners, guiding remediation and regulatory communications. Reporting directly to the Chief Quality Officer (CQO), this position is a key member of the Global Quality Leadership Team. Key Responsibilities Establishes and oversees a unified, process-centric Quality Management System (QMS) that spans the entire product lifecycle, ensuring continuous improvement, fit-for-purpose solutions, and simplification. Lead the development, implementation, and ongoing effectiveness of the global QMS in alignment with regulatory expectations across all enterprise functions. Drive Enterprise Quality Governance by setting quality metrics and KPIs to monitor performance and sustain improvement. Builds and develops a cross-divisional Global Process Owner Network that will develop and sustain the QMS working collaboratively with senior leaders across R&D, GPDS and Commercial. Oversees SOP governance, document control, training programs, data integrity and electronic quality systems (including AI governance). Designs and implements internal processes and communication mechanisms to assess emerging global regulatory expectations for impact on the organization and the overall BMS quality management system, to ensure ongoing compliance. Ensure these processes are linked to the broader regulatory policy forums in BMS at the enterprise level. working groups, etc. representing BMS strategic initiatives and input. Communicates effectively and builds cooperative and supportive working relationships across the Divisions and with external partners on quality, compliance and regulatory matter. Interfaces with members of the Divisional Leadership teams and the Quality Leadership Team. Engages and presents to BMS Leadership Team, CEO and BoD Board of Directors at the request and direction of CQO. Oversees and leads quality and compliance risk management initiatives to minimize risk and potential impact of quality and/or non-compliance events to the company. Builds and deploys Culture of Excellence plans to improve a culture of Quality across BMS. Ensures proactive quality and compliance oversight and adherence to QMS across internal operations and external partners through risk-based approaches, global inspection readiness, and independent audit. Provides quality and compliance expertise and oversight in support of significant compliance remediation, Health Authority inspection responses and actions, and regulatory communications including FARs, BPDRs, DPRs, etc. Actively engages with regulators and industry peers, representing BMS across industry and regulatory QMS forums to drive/leverage best practices, shares knowledge and industry/regulatory trends designed to continuously improve the QMS at BMS. Chairs the QMS Governance Forum responsible for overseeing the QMS operating model. Builds and continuously develops a high-performing global Quality team. Fosters a culture of accountability, integrity, collaboration, and innovation within Quality and across the Enterprise. Qualifications & Experience Minimum of 20+ years of BioPharma experience, with demonstrated experience in R&D and commercial manufacturing including pharmaceutical and biologics experience. Bachelor of Science in relevant Science (e.g. Chemistry, Biology, Chemical Engineering) or Engineering disciplines; and advanced degree (MBA, MS or PhD) preferred Extensive knowledge and experience in GxP global regulations necessary for appropriate decision making and representing BMS to regulatory agencies. Experience in leading a major quality discipline with GxP quality experience. Extensive experience in GLPs, GCPs, GPVP and GMPs (inclusive of medical devices). International regulatory experience in GxP environment. Previous proven experience dealing with FDA and other major regulatory agencies. Experience with digital innovation, including automation and Artificial Intelligence capabilities. Managed a large global operation involving diverse cultures and employees. Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management. In-depth experience in managing large teams, and in providing coaching, development and mentoring to employees. Experienced in advanced technology including technology transfer, e.g., R&D to manufacturing and/or between operations. Experience with managing a large budget. Experience in Computer System Validation, Analytical Methods development/transfer, Quality Systems, Product Quality complaint, combination Products/Device Quality. Position may require 20-30% travel on occasion. #LI-HYBRID If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: $373,380 - $452,448 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference. Vice President, Corporate Quality Client Services Celgene Corporation Biotechnology Pharmaceuticals Healthcare

The Vice President of Corporate Quality shapes and drives enterprise-wide quality strategies, manages regulatory compliance, and leads a global quality team. The role involves strategic leadership, regulatory engagement, and fostering a culture of excellence within the organization.

Bristol-Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a focus on oncology, immunology, cardiovascular, and fibrotic diseases, the company leverages science and technology to address unmet medical needs. Founded in 1887, Bristol-Myers Squibb has grown into a leading healthcare organization with a strong commitment to research and development, patient care, and global health. The company operates worldwide, providing therapies that improve the quality of life for millions of patients.

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary This global executive role shapes and drives the Corporate Quality vision, delivering strategic leadership and enterprise-wide quality and compliance across Bristol Myers Squibb. As a trusted advisor to senior leadership, the VP ensures alignment with business goals and global regulations, proactively managing quality risks and opportunities. The VP owns the global Quality Management System (QMS), championing its effectiveness and continuous improvement throughout the product lifecycle—from R&D to commercialization. Responsibilities include leading Quality Governance, setting enterprise KPIs, and overseeing SOPs, training, and digital quality systems (including GxP AI governance). With a forward-looking approach, this leader engages regulators and industry peers, anticipates emerging requirements, and ensures BMS remains inspection-ready and compliant. The role provides expert oversight for internal operations and external partners, guiding remediation and regulatory communications. Reporting directly to the Chief Quality Officer (CQO), this position is a key member of the Global Quality Leadership Team. Key Responsibilities Establishes and oversees a unified, process-centric Quality Management System (QMS) that spans the entire product lifecycle, ensuring continuous improvement, fit-for-purpose solutions, and simplification. Lead the development, implementation, and ongoing effectiveness of the global QMS in alignment with regulatory expectations across all enterprise functions. Drive Enterprise Quality Governance by setting quality metrics and KPIs to monitor performance and sustain improvement. Builds and develops a cross-divisional Global Process Owner Network that will develop and sustain the QMS working collaboratively with senior leaders across R&D, GPDS and Commercial. Oversees SOP governance, document control, training programs, data integrity and electronic quality systems (including AI governance). Designs and implements internal processes and communication mechanisms to assess emerging global regulatory expectations for impact on the organization and the overall BMS quality management system, to ensure ongoing compliance. Ensure these processes are linked to the broader regulatory policy forums in BMS at the enterprise level, working groups, etc. representing BMS strategic initiatives and input. Communicates effectively and builds cooperative and supportive working relationships across the Divisions and with external partners on quality, compliance and regulatory matter. Interfaces with members of the Divisional Leadership teams and the Quality Leadership Team. Engages and presents to BMS Leadership Team, CEO and BoD Board of Directors at the request and direction of CQO. Oversees and leads quality and compliance risk management initiatives to minimize risk and potential impact of quality and/or non-compliance events to the company. Builds and deploys Culture of Excellence plans to improve a culture of Quality across BMS. Ensures proactive quality and compliance oversight and adherence to QMS across internal operations and external partners through risk-based approaches, global inspection readiness, and independent audit. Provides quality and compliance expertise and oversight in support of significant compliance remediation, Health Authority inspection responses and actions, and regulatory communications including FARs, BPDRs, DPRs, etc. Actively engages with regulators and industry peers, representing BMS across industry and regulatory QMS forums to drive/leverage best practices, shares knowledge and industry/regulatory trends designed to continuously improve the QMS at BMS. Chairs the QMS Governance Forum responsible for overseeing the QMS operating model. Builds and continuously develops a high-performing global Quality team. Fosters a culture of accountability, integrity, collaboration, and innovation within Quality and across the Enterprise. Qualifications & Experience Minimum of 20+ years of BioPharma experience, with demonstrated experience in R&D and commercial manufacturing including pharmaceutical and biologics experience. Bachelor of Science in relevant Science (e.g. Chemistry, Biology, Chemical Engineering) or Engineering disciplines; and advanced degree (MBA, MS or PhD) preferred Extensive knowledge and experience in GxP global regulations necessary for appropriate decision making and representing BMS to regulatory agencies. Experience in leading a major quality discipline with GxP quality experience. Extensive experience in GLPs, GCPs, GPVP and GMPs (inclusive of medical devices). International regulatory experience in GxP environment. Previous proven experience dealing with FDA and other major regulatory agencies. Experience with digital innovation, including automation and Artificial Intelligence capabilities. Managed a large global operation involving diverse cultures and employees. Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management. In-depth experience in managing large teams, and in providing coaching, development and mentoring to employees. Experienced in advanced technology including technology transfer, e.g., R&D to manufacturing and/or between operations. Experience with managing a large budget. Experience in Computer System Validation, Analytical Methods development/transfer, Quality Systems, Product Quality complaint, combination Products/Device Quality. Position may require 20-30% travel on occasion. #LI-HYBRID If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: $373,380 - $452,448 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

The Vice President of Corporate Quality leads global quality and compliance strategies at Bristol Myers Squibb, ensuring enterprise-wide quality management and regulatory adherence.

United States

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary This global executive role shapes and drives the Corporate Quality vision, delivering strategic leadership and enterprise-wide quality and compliance across Bristol Myers Squibb. As a trusted advisor to senior leadership, the VP ensures alignment with business goals and global regulations, proactively managing quality risks and opportunities. The VP owns the global Quality Management System (QMS), championing its effectiveness and continuous improvement throughout the product lifecycle—from R&D to commercialization. Responsibilities include leading Quality Governance, setting enterprise KPIs, and overseeing SOPs, training, and digital quality systems (including GxP AI governance). With a forward-looking approach, this leader engages regulators and industry peers, anticipates emerging requirements, and ensures BMS remains inspection-ready and compliant. The role provides expert oversight for internal operations and external partners, guiding remediation and regulatory communications. Reporting directly to the Chief Quality Officer (CQO), this position is a key member of the Global Quality Leadership Team. Key Responsibilities Establishes and oversees a unified, process-centric Quality Management System (QMS) that spans the entire product lifecycle, ensuring continuous improvement, fit-for-purpose solutions, and simplification. Lead the development, implementation, and ongoing effectiveness of the global QMS in alignment with regulatory expectations across all enterprise functions. Drive Enterprise Quality Governance by setting quality metrics and KPIs to monitor performance and sustain improvement. Builds and develops a cross-divisional Global Process Owner Network that will develop and sustain the QMS working collaboratively with senior leaders across R&D, GPDS and Commercial. Oversees SOP governance, document control, training programs, data integrity and electronic quality systems (including AI governance). Designs and implements internal processes and communication mechanisms to assess emerging global regulatory expectations for impact on the organization and the overall BMS quality management system, to ensure ongoing compliance. Ensure these processes are linked to the broader regulatory policy forums in BMS at the enterprise level, working groups, etc. representing BMS strategic initiatives and input. Communicates effectively and builds cooperative and supportive working relationships across the Divisions and with external partners on quality, compliance and regulatory matter. Interfaces with members of the Divisional Leadership teams and the Quality Leadership Team. Engages and presents to BMS Leadership Team, CEO and BoD Board of Directors at the request and direction of CQO. Oversees and leads quality and compliance risk management initiatives to minimize risk and potential impact of quality and/or non-compliance events to the company. Builds and deploys Culture of Excellence plans to improve a culture of Quality across BMS. Ensures proactive quality and compliance oversight and adherence to QMS across internal operations and external partners through risk-based approaches, global inspection readiness, and independent audit. Provides quality and compliance expertise and oversight in support of significant compliance remediation, Health Authority inspection responses and actions, and regulatory communications including FARs, BPDRs, DPRs, etc. Actively engages with regulators and industry peers, representing BMS across industry and regulatory QMS forums to drive/leverage best practices, shares knowledge and industry/regulatory trends designed to continuously improve the QMS at BMS. Chairs the QMS Governance Forum responsible for overseeing the QMS operating model. Builds and continuously develops a high-performing global Quality team. Fosters a culture of accountability, integrity, collaboration, and innovation within Quality and across the Enterprise. Qualifications & Experience Minimum of 20+ years of BioPharma experience, with demonstrated experience in R&D and commercial manufacturing including pharmaceutical and biologics experience. Bachelor of Science in relevant Science (e.g. Chemistry, Biology, Chemical Engineering) or Engineering disciplines; and advanced degree (MBA, MS or PhD) preferred Extensive knowledge and experience in GxP global regulations necessary for appropriate decision making and representing BMS to regulatory agencies. Experience in leading a major quality discipline with GxP quality experience. Extensive experience in GLPs, GCPs, GPVP and GMPs (inclusive of medical devices). International regulatory experience in GxP environment. Previous proven experience dealing with FDA and other major regulatory agencies. Experience with digital innovation, including automation and Artificial Intelligence capabilities. Managed a large global operation involving diverse cultures and employees. Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management. In-depth experience in managing large teams, and in providing coaching, development and mentoring to employees. Experienced in advanced technology including technology transfer, e.g., R&D to manufacturing and/or between operations. Experience with managing a large budget. Experience in Computer System Validation, Analytical Methods development/transfer, Quality Systems, Product Quality complaint, combination Products/Device Quality. Position may require 20-30% travel on occasion. #LI-HYBRID If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: $373,380 - $452,448 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.Benefits:<ul><li> Health Coverage: Medical, pharmacy, dental, and vision care.</li><li> Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).</li><li> Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.</li><li> Work-life benefits include: Paid Time Off, flexible time off (unlimited, with manager approval), 11 paid national holidays, 160 hours annual paid vacation for new hires, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Years Day.</li></ul>

Bristol-Myers Squibb

Vice President, Corporate Quality The Vice President of Corporate Quality leads global quality and compliance strategies at Bristol Myers Squibb, ensuring enterprise-wide quality management and regulatory adherence. Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary This global executive role shapes and drives the Corporate Quality vision, delivering strategic leadership and enterprise-wide quality and compliance across Bristol Myers Squibb. As a trusted advisor to senior leadership, the VP ensures alignment with business goals and global regulations, proactively managing quality risks and opportunities. The VP owns the global Quality Management System (QMS), championing its effectiveness and continuous improvement throughout the product lifecycle—from R&D to commercialization. Responsibilities include leading Quality Governance, setting enterprise KPIs, and overseeing SOPs, training, and digital quality systems (including GxP AI governance). With a forward-looking approach, this leader engages regulators and industry peers, anticipates emerging requirements, and ensures BMS remains inspection-ready and compliant. The role provides expert oversight for internal operations and external partners, guiding remediation and regulatory communications. Reporting directly to the Chief Quality Officer (CQO), this position is a key member of the Global Quality Leadership Team. Key Responsibilities Establishes and oversees a unified, process-centric Quality Management System (QMS) that spans the entire product lifecycle, ensuring continuous improvement, fit-for-purpose solutions, and simplification. Lead the development, implementation, and ongoing effectiveness of the global QMS in alignment with regulatory expectations across all enterprise functions. Drive Enterprise Quality Governance by setting quality metrics and KPIs to monitor performance and sustain improvement. Builds and develops a cross-divisional Global Process Owner Network that will develop and sustain the QMS working collaboratively with senior leaders across R&D, GPDS and Commercial. Oversees SOP governance, document control, training programs, data integrity and electronic quality systems (including AI governance). Designs and implements internal processes and communication mechanisms to assess emerging global regulatory expectations for impact on the organization and the overall BMS quality management system, to ensure ongoing compliance. Ensure these processes are linked to the broader regulatory policy forums in BMS at the enterprise level, working groups, etc. representing BMS strategic initiatives and input. Communicates effectively and builds cooperative and supportive working relationships across the Divisions and with external partners on quality, compliance and regulatory matter. Interfaces with members of the Divisional Leadership teams and the Quality Leadership Team. Engages and presents to BMS Leadership Team, CEO and BoD Board of Directors at the request and direction of CQO. Oversees and leads quality and compliance risk management initiatives to minimize risk and potential impact of quality and/or non-compliance events to the company. Builds and deploys Culture of Excellence plans to improve a culture of Quality across BMS. Ensures proactive quality and compliance oversight and adherence to QMS across internal operations and external partners through risk-based approaches, global inspection readiness, and independent audit. Provides quality and compliance expertise and oversight in support of significant compliance remediation, Health Authority inspection responses and actions, and regulatory communications including FARs, BPDRs, DPRs, etc. Actively engages with regulators and industry peers, representing BMS across industry and regulatory QMS forums to drive/leverage best practices, shares knowledge and industry/regulatory trends designed to continuously improve the QMS at BMS. Chairs the QMS Governance Forum responsible for overseeing the QMS operating model. Builds and continuously develops a high-performing global Quality team. Fosters a culture of accountability, integrity, collaboration, and innovation within Quality and across the Enterprise. Qualifications & Experience Minimum of 20+ years of BioPharma experience, with demonstrated experience in R&D and commercial manufacturing including pharmaceutical and biologics experience. Bachelor of Science in relevant Science (e.g. Chemistry, Biology, Chemical Engineering) or Engineering disciplines; and advanced degree (MBA, MS or PhD) preferred Extensive knowledge and experience in GxP global regulations necessary for appropriate decision making and representing BMS to regulatory agencies. Experience in leading a major quality discipline with GxP quality experience. Extensive experience in GLPs, GCPs, GPVP and GMPs (inclusive of medical devices). International regulatory experience in GxP environment. Previous proven experience dealing with FDA and other major regulatory agencies. Experience with digital innovation, including automation and Artificial Intelligence capabilities. Managed a large global operation involving diverse cultures and employees. Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management. In-depth experience in managing large teams, and in providing coaching, development and mentoring to employees. Experienced in advanced technology including technology transfer, e.g., R&D to manufacturing and/or between operations. Experience with managing a large budget. Experience in Computer System Validation, Analytical Methods development/transfer, Quality Systems, Product Quality complaint, combination Products/Device Quality. Position may require 20-30% travel on occasion. #LI-HYBRID If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: $373,380 - $452,448 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference. Vice President, Corporate Quality Client Services Bristol-Myers Squibb Pharmaceuticals Biotechnology Healthcare

This executive role involves shaping and driving the company's quality vision, overseeing the global Quality Management System, and engaging with regulators and industry peers. The position reports to the Chief Quality Officer and is key to maintaining inspection readiness and continuous improvement.

Director

ResMed (NYSE: RMD) changes lives with award-winning medical devices and cloud-based software applications that better diagnose, treat and manage sleep apnea, chronic obstructive pulmonary disease (COPD) and other chronic diseases. ResMed is a global leader in connected care, with more than 3 million patients remotely monitored every day. Our 6,000-strong team is committed to creating the world's best tech-driven medical device company - improving quality of life, reducing the impact of chronic disease, and saving healthcare costs in more than 120 countries.

As Director Regulatory Affairs (Americas & ANZ), you set and lead the regulatory strategy for the Americas (US, Ca & Latin America) & ANZ regions, enabling commercial growth & innovation, geographic expansion, and manufacturing/supply‑chain transformations while ensuring rigorous compliance with global and regional regulations. You serve as the senior RA business partner to executive leadership, drive proactive regulatory planning, and ensure that regulatory realities are embedded in business strategy across Revenue, Marketing, Operations, Supply‑Chain in close collaboration with Quality, legal and other regional &amp; global RA leaders. Your role requires deep knowledge of medical device regulations in the US as well as a strong emphasis on strategic leadership, and hands-on execution across submissions, labelling and risk management processes. Let’s talk about Responsibilities Define and lead the Regulatory Affairs roadmap for Americas in alignment with global corporate strategy and regional Revenue ambitions. Represent Regulatory Affairs in regional leadership, commercial planning and strategic cross-functional meetings including but not limited to Revenue, Marketing, Supply Chain, Operations, Quality, Legal. Lead strategic high-complexity/ high-risk regulatory projects. Active member of the RA Leadership Team fostering collaboration and contributing to build the future of the Regulatory Affairs function Oversee the preparation &amp; submission of regulatory filings (including both product &amp; facility licensing/registration) within Americas for all class and type of Products Anticipate regulatory trends and shifts (US, Canada, LATAM, ANZ), shape proactive strategies (policy monitoring, engagement with regulators, participation in industry associations), influence external regulatory landscape as appropriate. Drive global-to-regional alignment: ensure Americas regulatory approach aligns with global RA standards while adapting to local market needs; propose harmonization initiatives for labeling, documentation, submission processes across region. Ensure robust compliance framework for Americas: audit readiness (MDSAP, ISO 13485, FDA QMS compliance), risk management, regulatory intelligence dissemination, crisis readiness (e.g., regulatory actions, recalls). Build, mentor and develop the Americas + ANZ RA organization: talent development, performance management, succession planning, ensure adequate skills and capacity to meet strategic demands. Serve as primary liaison with regulatory authorities (FDA, Health Canada, LATAM authorities) for major regulatory interactions, pre‑submission meetings, escalations, and to build trust and reputation of ResMed as compliance‑driven organization. Oversee budget, resources, external consultants/vendors for regulatory projects in Americas &amp; ANZ. Let’s talk about Qualifications &amp; Experiences Education &amp; experience Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or equivalent; advanced/regulatory certification (e.g., RAC) highly desirable. Minimum 10 years of regulatory affairs experience in medical devices (Class II/III, SaMD, combination products), with significant experience in Americas markets (US, Canada, LATAM). At least 3–5 years in a leadership role managing regulatory teams and interfacing with cross-functional business stakeholders. Knowledge &amp; Skills Deep knowledge of MD regulatory frameworks: FDA (21 CFR, QSR), Health Canada, ISO 13485/MDSAP, LATAM device regulations — demonstrated ability to navigate complex, multi‑jurisdictional regulatory environments. Strategic mindset and business acumen: ability to translate business goals into regulatory strategy, balance compliance and commercial objectives, drive enterprise‑level initiatives. Excellent stakeholder management, communication, influencing, and negotiation skills (internal leadership, external authorities, business partners). Fluent in English, with Spanish and/or Portuguese strongly preferred for LATAM coverage. Willingness to travel across Americas region; flexible to address regulatory or business needs globally as required. Leadership &amp; Behavioural Competencies Strategic vision &amp; foresight — anticipates regulatory trends, positions the company proactively. Executive presence — represents RA in senior leadership forums, builds credibility with regulators and internal stakeholders. Collaborative leadership — fosters cross-functional alignment, builds influence without direct authority across functions. Risk-based judgment &amp; integrity — ensures patient safety and compliance while enabling business growth. Talent development &amp; mentorship — builds a high-performing RA organization, develops skills, succession planning. Change management &amp; resilience — leads through regulatory changes, business expansions, organizational transformations. Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! Resmed (NYSE:RMD, ASX: RMD) creates life-changing health technologies that people love. We’re relentlessly committed to pioneering innovative technology to empower millions of people in more than 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices and intelligent software make home healthcare more personalized, accessible and effective. Ultimately, Resmed envisions a world where every person can achieve their full potential through better sleep and breathing, with care delivered in their own home. Learn more about how we’re redefining sleep health at Resmed.com and follow @Resmed.

Lead and manage regulatory strategies for the Americas and ANZ regions to ensure compliance and support business growth.

Director, Regulatory Affairs

As Director Regulatory Affairs (Americas & ANZ), you set and lead the regulatory strategy for the Americas (US, Ca & Latin America) & ANZ regions, enabling commercial growth & innovation, geographic expansion, and manufacturing/supply‑chain transformations while ensuring rigorous compliance with global and regional regulations. You serve as the senior RA business partner to executive leadership, drive proactive regulatory planning, and ensure that regulatory realities are embedded in business strategy across Revenue, Marketing, Operations, Supply‑Chain in close collaboration with Quality, legal and other regional &amp; global RA leaders. Your role requires deep knowledge of medical device regulations in the US as well as a strong emphasis on strategic leadership, and hands-on execution across submissions, labelling and risk management processes. Let’s talk about Responsibilities Define and lead the Regulatory Affairs roadmap for Americas in alignment with global corporate strategy and regional Revenue ambitions. Represent Regulatory Affairs in regional leadership, commercial planning and strategic cross-functional meetings including but not limited to Revenue, Marketing, Supply Chain, Operations, Quality, Legal. Lead strategic high-complexity/ high-risk regulatory projects. Active member of the RA Leadership Team fostering collaboration and contributing to build the future of the Regulatory Affairs function Oversee the preparation &amp; submission of regulatory filings (including both product &amp; facility licensing/registration) within Americas for all class and type of Products Anticipate regulatory trends and shifts (US, Canada, LATAM, ANZ), shape proactive strategies (policy monitoring, engagement with regulators, participation in industry associations), influence external regulatory landscape as appropriate. Drive global-to-regional alignment: ensure Americas regulatory approach aligns with global RA standards while adapting to local market needs; propose harmonization initiatives for labeling, documentation, submission processes across region. Ensure robust compliance framework for Americas: audit readiness (MDSAP, ISO 13485, FDA QMS compliance), risk management, regulatory intelligence dissemination, crisis readiness (e.g., regulatory actions, recalls). Build, mentor and develop the Americas + ANZ RA organization: talent development, performance management, succession planning, ensure adequate skills and capacity to meet strategic demands. Serve as primary liaison with regulatory authorities (FDA, Health Canada, LATAM authorities) for major regulatory interactions, pre‑submission meetings, escalations, and to build trust and reputation of ResMed as compliance‑driven organization. Oversee budget, resources, external consultants/vendors for regulatory projects in Americas &amp; ANZ. Let’s talk about Qualifications &amp; Experiences Education &amp; experience Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or equivalent; advanced/regulatory certification (e.g., RAC) highly desirable. Minimum 10 years of regulatory affairs experience in medical devices (Class II/III, SaMD, combination products), with significant experience in Americas markets (US, Canada, LATAM). At least 3–5 years in a leadership role managing regulatory teams and interfacing with cross-functional business stakeholders. Knowledge &amp; Skills Deep knowledge of MD regulatory frameworks: FDA (21 CFR, QSR), Health Canada, ISO 13485/MDSAP, LATAM device regulations — demonstrated ability to navigate complex, multi‑jurisdictional regulatory environments. Strategic mindset and business acumen: ability to translate business goals into regulatory strategy, balance compliance and commercial objectives, drive enterprise‑level initiatives. Excellent stakeholder management, communication, influencing, and negotiation skills (internal leadership, external authorities, business partners). Fluent in English, with Spanish and/or Portuguese strongly preferred for LATAM coverage. Willingness to travel across Americas region; flexible to address regulatory or business needs globally as required. Leadership &amp; Behavioural Competencies Strategic vision &amp; foresight — anticipates regulatory trends, positions the company proactively. Executive presence — represents RA in senior leadership forums, builds credibility with regulators and internal stakeholders. Collaborative leadership — fosters cross-functional alignment, builds influence without direct authority across functions. Risk-based judgment &amp; integrity — ensures patient safety and compliance while enabling business growth. Talent development &amp; mentorship — builds a high-performing RA organization, develops skills, succession planning. Change management &amp; resilience — leads through regulatory changes, business expansions, organizational transformations. Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! Resmed (NYSE:RMD, ASX: RMD) creates life-changing health technologies that people love. We’re relentlessly committed to pioneering innovative technology to empower millions of people in more than 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices and intelligent software make home healthcare more personalized, accessible and effective. Ultimately, Resmed envisions a world where every person can achieve their full potential through better sleep and breathing, with care delivered in their own home. Learn more about how we’re redefining sleep health at Resmed.com and follow @Resmed.Requirements:<ul><li> Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or equivalent</li><li> Advanced/regulatory certification (e.g., RAC) highly desirable</li><li> Minimum 10 years of regulatory affairs experience in medical devices (Class II/III, SaMD, combination products)</li><li> Significant experience in Americas markets (US, Canada, LATAM)</li><li> At least 3–5 years in a leadership role managing regulatory teams and interfacing with cross-functional business stakeholders</li><li> Deep knowledge of MD regulatory frameworks: FDA (21 CFR, QSR), Health Canada, ISO 13485/MDSAP, LATAM device regulations</li><li> Ability to navigate complex, multi-jurisdictional regulatory environments</li><li> Strategic mindset and business acumen</li><li> Excellent stakeholder management, communication, influencing, and negotiation skills</li><li> Fluent in English, with Spanish and/or Portuguese strongly preferred</li><li> Willingness to travel across Americas region</li></ul>Benefits:<ul><li> Diverse and inclusive culture</li><li> Supportive and inspiring work environment</li><li> Opportunities for career growth and development</li><li> Work in a challenging and innovative environment</li></ul>

ResMed

Director, Regulatory Affairs Lead and manage regulatory strategies for the Americas and ANZ regions to ensure compliance and support business growth. As Director Regulatory Affairs (Americas & ANZ), you set and lead the regulatory strategy for the Americas (US, Ca & Latin America) & ANZ regions, enabling commercial growth & innovation, geographic expansion, and manufacturing/supply‑chain transformations while ensuring rigorous compliance with global and regional regulations. You serve as the senior RA business partner to executive leadership, drive proactive regulatory planning, and ensure that regulatory realities are embedded in business strategy across Revenue, Marketing, Operations, Supply‑Chain in close collaboration with Quality, legal and other regional &amp; global RA leaders. Your role requires deep knowledge of medical device regulations in the US as well as a strong emphasis on strategic leadership, and hands-on execution across submissions, labelling and risk management processes. Let’s talk about Responsibilities Define and lead the Regulatory Affairs roadmap for Americas in alignment with global corporate strategy and regional Revenue ambitions. Represent Regulatory Affairs in regional leadership, commercial planning and strategic cross-functional meetings including but not limited to Revenue, Marketing, Supply Chain, Operations, Quality, Legal. Lead strategic high-complexity/ high-risk regulatory projects. Active member of the RA Leadership Team fostering collaboration and contributing to build the future of the Regulatory Affairs function Oversee the preparation &amp; submission of regulatory filings (including both product &amp; facility licensing/registration) within Americas for all class and type of Products Anticipate regulatory trends and shifts (US, Canada, LATAM, ANZ), shape proactive strategies (policy monitoring, engagement with regulators, participation in industry associations), influence external regulatory landscape as appropriate. Drive global-to-regional alignment: ensure Americas regulatory approach aligns with global RA standards while adapting to local market needs; propose harmonization initiatives for labeling, documentation, submission processes across region. Ensure robust compliance framework for Americas: audit readiness (MDSAP, ISO 13485, FDA QMS compliance), risk management, regulatory intelligence dissemination, crisis readiness (e.g., regulatory actions, recalls). Build, mentor and develop the Americas + ANZ RA organization: talent development, performance management, succession planning, ensure adequate skills and capacity to meet strategic demands. Serve as primary liaison with regulatory authorities (FDA, Health Canada, LATAM authorities) for major regulatory interactions, pre‑submission meetings, escalations, and to build trust and reputation of ResMed as compliance‑driven organization. Oversee budget, resources, external consultants/vendors for regulatory projects in Americas &amp; ANZ. Let’s talk about Qualifications &amp; Experiences Education &amp; experience Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or equivalent; advanced/regulatory certification (e.g., RAC) highly desirable. Minimum 10 years of regulatory affairs experience in medical devices (Class II/III, SaMD, combination products), with significant experience in Americas markets (US, Canada, LATAM). At least 3–5 years in a leadership role managing regulatory teams and interfacing with cross-functional business stakeholders. Knowledge &amp; Skills Deep knowledge of MD regulatory frameworks: FDA (21 CFR, QSR), Health Canada, ISO 13485/MDSAP, LATAM device regulations — demonstrated ability to navigate complex, multi‑jurisdictional regulatory environments. Strategic mindset and business acumen: ability to translate business goals into regulatory strategy, balance compliance and commercial objectives, drive enterprise‑level initiatives. Excellent stakeholder management, communication, influencing, and negotiation skills (internal leadership, external authorities, business partners). Fluent in English, with Spanish and/or Portuguese strongly preferred for LATAM coverage. Willingness to travel across Americas region; flexible to address regulatory or business needs globally as required. Leadership &amp; Behavioural Competencies Strategic vision &amp; foresight — anticipates regulatory trends, positions the company proactively. Executive presence — represents RA in senior leadership forums, builds credibility with regulators and internal stakeholders. Collaborative leadership — fosters cross-functional alignment, builds influence without direct authority across functions. Risk-based judgment &amp; integrity — ensures patient safety and compliance while enabling business growth. Talent development &amp; mentorship — builds a high-performing RA organization, develops skills, succession planning. Change management &amp; resilience — leads through regulatory changes, business expansions, organizational transformations. Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! Resmed (NYSE:RMD, ASX: RMD) creates life-changing health technologies that people love. We’re relentlessly committed to pioneering innovative technology to empower millions of people in more than 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices and intelligent software make home healthcare more personalized, accessible and effective. Ultimately, Resmed envisions a world where every person can achieve their full potential through better sleep and breathing, with care delivered in their own home. Learn more about how we’re redefining sleep health at Resmed.com and follow @Resmed. Director AI Engineer ResMed medical-devices healthcare medical-equipment respiratory-conditions biotechnology copd cpap digital-health durable-medical-equipment fitness health health-care health-it healthcare-informatics home-medical-equipment hospital interoperability life-support manufacturing medical-equipment-manufacturing medical-software out-of-hospital-care patient-engagement portable-oxygen remote-monitoring remote-patient-monitoring respiratory-care saas sleep sleep-apnea ventilation wellness

This role involves defining regulatory roadmaps, overseeing submissions, and building relationships with authorities across the Americas and ANZ. It requires strategic leadership, deep regulatory knowledge, and cross-functional collaboration.

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