Associate Director, GMP Quality

Role: Associate Director, GMP Quality, overseeing manufacturing quality assurance for Olema's clinical and commercial small molecule products, primarily Active Pharmaceutical Ingredients. Responsibilities include batch disposition and release, technical review of batch and analytical records, oversight of CMO operations, and support for regulatory inspections and submissions. The role involves collaboration with CMC, Regulatory, and Supply Chain teams to ensure compliance and quality standards. Requirements: Bachelor's degree (advanced degree preferred), minimum 8 years in FDA-regulated pharmaceutical GMP/QA roles, with experience in small molecule synthesis, analytical testing, NDA/BLA submissions, and managing CMO relationships. Proficiency with GMP standards (21 CFR Parts 210/211, ICH Q7), Quality Management Systems (e.g., Veeva, TrackWise), and strong communication skills are essential. Preferred attributes include leadership, collaboration, and problem-solving capabilities. The position is based in San Francisco or Boston, with 10-15% travel, some international, and involves reviewing and authoring GMP documentation, supporting product release, and participating in inspections. High-value biopharma specifics include focus on small molecule drug substances, late-stage clinical development (Phase 3), and regulatory compliance for potential NDA submission.