Associate Director, GMP Quality Assurance

Role: Associate Director, GMP Quality Assurance overseeing development, transfer, manufacture, testing, and batch disposition of small molecule Drug Substance and Drug Product Intermediate for late-stage clinical programs. Responsibilities: ensure GMP compliance, review batch records, deviations, investigations, change controls, and support technology transfer, validation, inspections, and lifecycle changes. Collaborate with Technical Operations, CMC, Regulatory, Supply Chain, and external CDMOs to maintain inspection readiness and quality systems. Requirements: Bachelor's in a scientific or technical field; 10+ years GMP QA experience in late-stage or commercial small molecule manufacturing; expertise in process chemistry, analytical testing, GMP regulations, and inspection readiness. Preferred: experience with post-approval changes and commercial batch disposition. High-value biopharma specifics: focus on RAS(ON) inhibitors in oncology, supporting clinical development stages with global GMP oversight. Work setup: not specified.