Director, Good Manufacturing Processes, Quality Assurance

IDEAYA Biosciences seeks a Director of Good Manufacturing Processes and Quality Assurance to lead GMP QA oversight for drug products and biologics from toxicology through Phase 3 clinical trials. The role ensures compliance across CMC, manufacturing development, and IT systems while providing strategic quality leadership to internal teams and external partners. Based in South Francisco with four-day onsite requirement.

Responsibilities

• Lead GMP QA strategy and compliance oversight for drug product and biologics development programs
• Serve as primary Quality lead for clinical trial materials, including drug substance and product review
• Oversee vendor and CDMO management, including audits, agreements, and qualification activities
• Review and approve deviations, corrective actions, change controls, and development documentation
• Drive quality system improvements and regulatory submission support across development pipeline

Requirements

• Extensive GMP and quality assurance experience in pharmaceutical or biologics development
• Leadership experience overseeing QA functions across preclinical through Phase 3 programs
• Deep knowledge of CMC, manufacturing development, and regulatory compliance requirements
• Experience managing contract development and manufacturing organizations (CDMOs) and vendor qualification
• Proficiency with quality system documentation, deviation management, and CAPA processes
• Cross-functional collaboration skills with regulatory, clinical, and manufacturing teams