Associate Director, GMP Quality

Role: Associate Director, GMP Quality overseeing manufacturing quality for small molecule drug substances (API) in a biopharma setting, primarily supporting clinical and commercial production. Responsibilities: review and approve batch records, Certificate of Analysis, deviations, CAPAs, and change controls; oversee CMO operations and audits; support regulatory filings, including NDA submissions; ensure compliance during pre-approval inspections; and generate quality metrics. Requirements: Bachelor's degree (advanced degrees preferred); 8+ years in FDA-regulated pharma GMP/QA roles with experience in small molecule synthesis, analytical data review, and CMO management; familiarity with cGMP standards (21 CFR Parts 210/211, ICH Q7); prior NDA/BLA experience and regulatory interaction skills; proficiency in Quality Management Systems like Veeva or TrackWise. Preferred skills include strong leadership, communication, and collaboration abilities, with a focus on quality and compliance. High-Value: GMP QA for small molecules, drug substance manufacturing, NDA/bioBLA submission, regulatory compliance, CMO oversight, and international travel (10-15%). Work Setup: based in San Francisco or Boston.