Associate Director, GMP Quality

Role: Associate Director, GMP Quality overseeing manufacturing and quality assurance of small molecule drug substances (APIs) for Olema's clinical and commercial products. Responsibilities: review and approve batch records, Certificates of Analysis, deviations, CAPAs, and change controls; oversee CMO operations and conduct supplier audits; support regulatory submissions, including NDA readiness and product quality reviews; represent GMP quality during inspections; author SOPs and generate quality metrics. Requirements: Bachelor's degree (advanced degree preferred); 8+ years in FDA-regulated pharmaceutical GMP QA roles; experience with small molecules, analytical testing, NDA/BLA submissions, and CMO management; proficiency in GMP standards (21 CFR Parts 210/211, ICH Q7) and quality systems (Veeva, TrackWise). Preferred: leadership, collaboration, strong communication skills, and ability to work independently. High-Value: focus on small molecule APIs, GMP compliance, regulatory filings, and quality oversight for clinical and commercial stages. Work setup: based in San Francisco or Boston, with 10-15% travel, some international.