Braveheart Bio, Inc.
51-200 employees
Biotechnology
Pharmaceuticals
Life Sciences
About Braveheart Bio, Inc.
Braveheart Bio, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies for patients with serious and rare diseases. The company specializes in leveraging its proprietary technology platforms to create novel biologics and antibody-based therapeutics. Braveheart Bio aims to address unmet medical needs by advancing a pipeline of product candidates through rigorous clinical development. Their mission is to improve patient outcomes by delivering transformative medicines with a focus on precision and safety.
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Description
- Braveheart Bio, a Bay Area–based biopharmaceutical company, is seeking a (Senior) Director of Quality to serve as a senior quality leader responsible for clinical and nonclinical quality oversight, data privacy, GDPR, and inspection readiness for their late-stage clinical program targeting hypertrophic cardiomyopathy.
- The role involves establishing and executing oversight frameworks, guiding clinical development teams, and preparing for regulatory submissions and commercialization.
- The leader will partner with Clinical Development, Regulatory, Biometrics, PV, CMC, and external CROs and vendors to ensure quality across all programs.
- The position may include building and leading a small quality team.
- Responsibilities include leading quality strategy, GCP/GLP oversight, audits, compliance, GDPR/data privacy, cross-functional collaboration, and broader GxP support.
- The ideal candidate has at least 10 years of GxP quality experience, deep knowledge of global regulations, and experience in late-stage clinical development, with a focus on GDPR and clinical data privacy.
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Requirements
- Bachelor’s degree in life sciences or related discipline; advanced degree preferred
- At least 10 years of GxP quality experience, including deep experience in GCP oversight and global clinical development
- Strong knowledge of global GxP regulations (GCP, GLP, GMP, GVP, GDP as applicable) and regulatory expectations for late-stage clinical programs
- Proven success establishing and executing clinical and nonclinical oversight in a small or emerging biotech environment
- Experience developing audit strategies, overseeing vendors and CROs, and supporting inspection readiness and regulatory interactions
- Demonstrated expertise in GDPR and clinical data-privacy compliance, including implementation and management of privacy-related processes in collaboration with Legal
- Demonstrated experience with computerized system validation for clinical and nonclinical systems in a regulated environment
- Ability to assess risk, solve complex problems, and implement practical, scalable quality solutions
- Strong written and verbal communication skills with a collaborative, team-oriented approach
- Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity
- Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude
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Benefits
- Competitive salary
- Opportunity to work in a mission-driven biotech focused on cardiovascular disease
- Potential to build and lead a small quality team
- Collaborative, fast-paced environment
- Inclusion and diversity commitment