Manager, GMP Quality Operations

Role: GMP Quality Operations Manager overseeing external manufacturing and testing activities supporting late-stage clinical and commercial biopharma programs. Responsibilities: manage deviations, investigations, batch record reviews, change controls, and product disposition; ensure compliance with cGMP, ICH, and regulatory standards; support technology transfer, process validation, and inspection readiness; collaborate with CDMOs, QPs, and cross-functional teams to maintain quality and operational excellence. Requirements: Bachelor's in Life Sciences, Chemistry, Engineering, or related field; 7+ years in GMP Quality Operations within pharma/biotech; hands-on experience with batch review, investigations, deviations, CAPA, and change control; familiarity with small molecule manufacturing, sterile injectables, drug-device combos, and global GMP regulations (FDA, EMA, ICH). Preferred: experience supporting late-stage clinical or commercial manufacturing, external CDMO oversight, and technology transfer; knowledge of scale-up, process validation, and product release. HighValue: late-stage clinical and commercial manufacturing, GMP compliance, CDMO interface, sterile and combination products, global regulatory standards, 25% travel. WorkSetup: onsite in San Diego, CA; periodic travel.