Director, Manufacturing Processes, Quality Assurance

Overview

Director, Good Manufacturing Processes, Quality Assurance role at IDEAYA Biosciences
. This position leads GMP QA oversight for drug products and biologics programs from toxicology through Phase 3, providing strategic Quality leadership across internal teams and external partners. The role is onsite in South San Francisco four days per week.

• Collaborate to provide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards.
• Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase studies.
• Collaborate cross-functionally with Information Technology staff to support computer system validation activities.
• Oversee QA support for development-stage manufacturing, analytical, and including review and approval of deviations, CAPAs, change controls, and protocol/reports.
• Collaborate cross-functionally with CMC staff, Regulatory Affairs, Clinical Operations, and Program Management to drive proactive Quality input into development programs.
• Provide Quality oversight of contract development and manufacturing organizations (CDMOs), and other GxP service providers (vendors) used for clinical trial materials and services. Establish QA-QA relationships and checkpoints for critical CDMOs and service providers.
• Lead or support Quality Agreements, risk assessments, audits, and service provider (vendor) qualification activities to ensure phase-appropriate compliance.
• Actively represent QA in technical development activities, including process development, method validation/transfer, batch record reviews, formulation work, scale-up (commercialization), and computer systems validation.
• Collaborate on phase-appropriate quality system improvements for development-stage programs.
• Participate in Quality governance forums, providing expert input on GMP requirements and ensuring alignment with global Quality strategy.
• Support regulatory submissions (e.g., IND, IMPD, BLA sections) by reviewing or contributing Quality input and documentation.
• Create, maintain, and enhance Standard Operating Procedures governing Development QA activities.
• Support investigations and root cause analysis of product or process issues related to clinical manufacturing.
• Drive Quality input into lifecycle changes, process optimizations, and continuous improvement initiatives across development programs.
• Responsible for final product Quality release/rejection and related processes.
• Support service provider and internal audits as necessary.
• Support oversight of Third-Party Logistics compliance.
• Create and maintain Standard Operating Procedures related to areas of responsibility including product release, design control, change management, technology transfer, etc.
• Host and support regulatory inspections, ensuring inspection readiness and timely resolution of findings. Represent GMP QA in regulatory inspections, partner audits, and due diligence activities.
• Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards.
• Additional responsibilities and duties as assigned.

• BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, Pharm
  
  D) strongly preferred.
• Minimum of 12 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 8 years supporting development-stage programs; advanced degree may substitute for years of experience.
• Minimum 5 years of direct GxP experience (GMP, GCP, GPV, and/or GLP) in a regulated environment supporting small molecule drug products and biologics.
• Minimum 3 years of direct GxP experience supporting computer systems validation.
• Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Part 210/211, 600s, ICH, EU Annexes, GAMP5, ISO 9001, ISO 27001), and compliance expectations across clinical development.
• Proven track record in QA oversight of CDMOs, CROs, and testing labs, including audit and service provider management experience.
• Experience hosting regulatory inspections (e.g., FDA, EMA, PMDA) and managing Ideaya audit programs.
• Experience supporting regulatory submissions (e.g. IND, IMPD, BLA/MAA, NDA) with high-quality documentation and Quality strategy input.
• Exceptional leadership and team-building skills, strong analytical, problem-solving, and decision-making abilities.
• Effective communicator and cross-functional collaborator with the ability to influence across technical and strategic levels.
• Highly organized with sharp attention to detail, analytical thinking, and strong decision-making skills.
• Proficient in Microsoft Office and quality system tools (e.g. Veeva, ACE Inspection, etc.), Microsoft SharePoint, Microsoft Visio, and Egnyte.
• Strong knowledge of computer system validation processes is preferred.

The expected salary range for the role of Director, Good Manufacturing Processes,…