Associate Director, Product Quality Assurance

Role: Associate Director of Product Quality Assurance overseeing GMP quality for internal and external manufacturing and analytical activities in a biotech focused on precision gene editing. Responsibilities: manage quality compliance for analytical testing, instrument qualification, and manufacturing across external CDMOs and internal teams; develop and monitor quality systems; lead investigations, audits, and deviations; ensure batch record accuracy and product release; provide GxP guidance and oversight. Qualifications: BSc/Advanced degree in a scientific discipline; 12+ years in pharma/biotech with biologics experience; 3+ years managing CDMOs and QA systems; strong knowledge of cGMP regulations for clinical and commercial biologics; experience with regulatory audits and inspections; proven leadership and cross-functional collaboration skills. HighValue: biologics, gene editing, GMP manufacturing, analytical validation, CDMO oversight, GxP compliance, clinical to commercial phase. WorkSetup: not specified; likely hybrid or on-site given the nature of GMP oversight.