Director, GMP QA Operations

Role: Director of GMP QA Operations overseeing quality assurance for clinical and commercial products in an oncology-focused biopharma. Responsibilities: lead QA activities across external manufacturing, including Drug Substance, Drug Product, and Finished Product; review batch records, deviations, investigations, and batch disposition; ensure GMP compliance, inspection readiness, and quality risk management; support regulatory filings, inspections, and lifecycle activities; provide leadership and mentorship to QA teams. Requirements: Bachelor's in a scientific/technical discipline; 12+ years in GMP Quality, with 5+ years managerial experience; extensive support of small molecule manufacturing, especially oral solid dosage forms; strong knowledge of GMP regulations, batch release, and external partner oversight. Preferred: experience with commercial batch disposition, global supply, and post-approval lifecycle. HighValue: GMP quality oversight for small molecule manufacturing, clinical to commercial phases, supporting external manufacturing networks, and regulatory compliance within oncology drug development. WorkSetup: on-site in Redwood City, CA, with a salary range of $211,000–$264,000 USD.