Director, Good Manufacturing Processes, Quality Assurance

Role Director of GMP Quality Assurance at IDEAYA Biosciences, overseeing quality operations for drug products and biologics from toxicology through Phase 3. Responsibilities provide strategic and operational GMP compliance leadership across CMC, manufacturing, and IT systems; lead QA support for clinical trial materials; manage vendor and contract manufacturing oversight; support regulatory submissions and inspections; develop and maintain quality systems and SOPs; and drive continuous improvement initiatives. Requirements BS in Life Sciences, Chemistry, Engineering, or related; 12+ years of biopharma QA experience, including at least 8 years supporting development-stage programs; 5+ years in GxP environments supporting small molecules and biologics; expertise in GMP compliance, regulatory requirements (FDA, EMA, ICH), and vendor management; proven experience with clinical manufacturing, analytical validation, and regulatory audits. Preferred advanced degree (MS, PhD, PharmD). High-Value biologics and small molecules, development through Phase 3, GxP compliance, cross-functional collaboration with CMC, regulatory, clinical ops, and vendors, and experience hosting regulatory inspections. WorkSetup onsite in South San Francisco, CA, four days/week, with travel up to 10% domestically and internationally. #J-18808-Ljbffr Scorpion Therapeutics