Director, Good Manufacturing Practices & Computer System Validation Quality Assurance

Role Summary

Director of Good Manufacturing Practices and Computer System Validation Quality Assurance to join our IDEAYA Quality team. The Director, GMP & CSV QA is a leadership role responsible for developing and maintaining GMP and CSV Quality Systems, supporting internal and external compliance activities, and overseeing deviation, CAPA, change control, and batch release processes. Acts as QA liaison to project teams to ensure regulatory and company standard compliance for manufacturing, testing, release, and distribution of clinical and commercial products. Reports to the Vice President, Quality.

Responsibilities

• Develop and implement the global GMP & CSV QA strategy aligned with corporate goals, SOPs, and regulatory requirements.
• Ensure compliance with global GMP regulations (FDA, EMA, PMDA, ICH Q7, Q10) and company standards.
• Develop procedures and workflows for key Quality Systems (Deviation, CAPA, Change Control, Document management) to support GxP activities.
• Oversee GMP QA policies, quality agreements, SOPs, and quality systems processes to manage quality events.
• Manage all aspects of GxP quality functions for clinical and commercial products (Lot Release, QA records, Deviations, Change Control, Complaints, Audits, APQR).
• Monitor regulatory trends and proactively adapt QA processes.
• Compile and track quality metrics (KPI) and report to management quarterly.
• Lead GMP audit programs (internal and external) including CMOs, suppliers, and laboratories; host and support regulatory inspections.
• Review and approve audit reports, CAPA plans, and follow-up actions; oversee APQR process.
• Drive continuous improvement based on KPIs, APQR findings, and trends.
• Identify, assess, and mitigate GMP-related risks across the supply chain and manufacturing processes.
• Provide expert guidance on GMP & CSV compliance and escalate critical issues to cross-functional teams and senior management.
• Collaborate with manufacturing, supply chain, regulatory affairs, and other stakeholders to address quality issues and improve processes.
• Build, mentor, and lead a high-performing GMP & CSV QA team; foster a culture of quality and collaboration.
• Partner with CMC, regulatory affairs, IT, and R&D to align on quality and compliance objectives.
• Support development and review of batch records, specifications, test methods, protocols, and other critical documents.
• Oversee vendor qualification and monitoring of GMP contractors, suppliers, and testing laboratories; ensure vendor compliance with contractual obligations and regulatory requirements.

Qualifications

• Advanced degree in life sciences, pharmacy, chemistry, or related field (PhD, MS, or equivalent preferred).
• Minimum 12 years in the pharmaceutical/biotech industry, with at least 8 years in GMP QA or manufacturing quality in a company with in-house manufacturing.
• Proven track record leading GMP QA functions within a global organization; ability to work in a fast-paced environment.
• Strong knowledge of global GMP & CSV regulations, ICH guidelines, and manufacturing processes.
• Experience hosting regulatory inspections (FDA, EMA, PMDA) and managing audit programs.
• Excellent leadership, analytical, problem-solving, and decision-making abilities; strong communication and interpersonal skills.
• Strategic thinker with focus on continuous improvement and innovation.
• Willingness to travel up to 20% for audits, inspections, and meetings.

Skills

• GMP, CSV, QA leadership, regulatory inspections, risk management, CAPA, deviation management, change control, document management
• Quality systems development, vendor management, audits, APQR, KPI tracking
• Cross-functional collaboration, mentorship, strategic planning, problem solving

Education

• Advanced degree in life sciences, pharmacy, chemistry, or related field (PhD, MS, or equivalent preferred).

Additional Requirements

• Onsite work four days per week at South San Francisco headquarters.