Celgene Corporation
5001-10000 employees
Biotechnology
Pharmaceuticals
Healthcare
About Celgene Corporation
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.
3 months ago
Vice President, Corporate Quality
Full-time
Mid Level
Vice President, Corporate Quality
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Description
- 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.
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Benefits
- Wide variety of competitive benefits, services and programs that provide resources to pursue personal and professional goals.
- 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 including flexible time off (unlimited, with manager approval), 11 paid national holidays, 160 hours annual paid vacation, and optional holidays.
- 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.