Director, Manufacturing Processes, Quality Assurance

Director of GMP Quality Assurance at IDEAYA Biosciences, overseeing quality operations for drug products and biologics from toxicology through Phase 3.

• 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.

• 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.

• advanced degree (MS, PhD, PharmD).

• 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.

• onsite in South San Francisco, CA, four days/week, with travel up to 10% domestically and internationally.