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.