Director, Good Manufacturing Processes, Quality Assurance
IDEAYA Biosciences
Summary
The Director, GMP, Quality Assurance will lead GMP QA oversight for drug products and biologics programs from toxicology through Phase 3. This role ensures phase-appropriate GMP compliance across CMC, manufacturing development, and IT Systems, while providing strategic Quality leadership across internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.
Job description
What you'll do
- 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, clinical supply chain (including IMP release and product quality resolution), 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 assigned.
- All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA's Code of Conduct.
- Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels.
Requirements
- BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) 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.
- Demonstrated success in QA oversight of CDMOs, CROs, and testing labs, including audit and service provider management experience.
- Proven track record and relevant industry experience in leading GMP QA functions within a global organization. Flexibility to work in a fast-paced, dynamic environment with evolving priorities.
- Direct experience with clinical manufacturing, analytical method development / validation, tech transfer, and pharmaceutical development.
- Experience hosting regulatory inspections (e.g., FDA, EMA, PMDA) and managing Ideaya audit programs.
Benefits
- Medical, Dental & Vision
- 401(k)
- ESPP
- Wellness Programs
- Short-Term Incentive Plan
- Stock Option Awards
Company overview
IDEAYA Biosciences is a clinical-stage precision medicine oncology company headquartered in South San Francisco, California. Founded in 2015, the company is dedicated to the discovery, development, and commercialization of transformative therapies for cancer patients. IDEAYA's innovative approach integrates expertise in small-molecule drug discovery, structural biology, and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers. The company focuses on developing tailored, potentially first-in-class targeted therapies aligned with the genetic drivers of disease, with a primary emphasis on synthetic lethality – an emerging class of precision medicine targets. IDEAYA has built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates (ADCs) for molecularly defined solid tumor indications. The company's mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized, with the goal of altering the course of disease and improving clinical outcomes for cancer patients. IDEAYA went public on NASDAQ in May 2019 (NASDAQ: IDYA) and has established strategic collaborations with major pharmaceutical companies including Pfizer, Gilead Sciences, and GlaxoSmithKline.