BioMarin is seeking a Senior Director, Head of Product Quality Leaders (PQL) to lead a portfolio-aligned Product Quality team and provide strategic and people leadership for PQLs and Device Quality. The role is responsible for ensuring consistent, phase-appropriate Quality input into CMC strategy, regulatory filings, and lifecycle decision-making for clinical and commercial products.
Requirements
- BA/BS in life sciences or related field
- 15+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry
- Experience leading product-focused Quality roles embedded with CMC teams across clinical and commercial stages
- Strong experience with building and sustaining cross-functional relationships with key stakeholders
- Experience with influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environment
- In-depth understanding and application of cGMP principles, concepts, practices and standards
- Strong working knowledge of Module 3 Quality expectations
- Broad range of knowledge and experience in Quality with biologic and chemical processes, drug development, analytical methods
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Tuition Reimbursement
