Director, Product Quality Leader (PQL)
BioMarin Pharmaceutical — United States
Posted: 2026-09-28
Job Description
• Director-level Product Quality Leader serving as the technical quality expert and single quality point of contact for assigned products across clinical development through post-commercialization.
• Leads CMC quality strategy, Quality Partner Team deliverables, product quality risk management, product specifications, QTPP development, comparability protocols, and cross-functional quality initiatives.
• Reviews regulatory submissions, applies 21CFR, USP, EP, JP, ICH, and cGMP requirements, and oversees Health Authority commitments and Annual Product Reviews.
• Requires a BA/BS in life sciences or a related field and 12+ years of experience in biotechnology, pharmaceutical, medical device, or another highly regulated industry; advanced degree desirable.
• Full-time role based in the United States; work mode is not specified; periodic travel required; salary range is $176,000–$242,000.