Director Quality Engineering Jobs in San Ramon, CA

Non‑Solicitation Policy and Notice to Agencies and Recruiters: IDEAYA’s Non‑Solicitation Policy strictly prohibits agencies and recruiters from contacting IDEAYA employees, managers, or leaders to submit unsolicited candidate resumes or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters will not create any implied obligation. Failure to comply will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting decisions are managed by the internal IDEAYA Human Resources function. External agencies and recruiters must direct all communication to humanresources@ideayabio.com. We ask that you only email your interest once.

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. We integrate expertise in small‑molecule drug discovery, structural biology, bioinformatics, and biomarker validation to develop tailored, potentially first‑in‑class targeted therapies aligned with the genetic drivers of disease. Our pipeline focuses on synthetic lethality and antibody‑drug conjugates (ADCs) for molecularly defined solid tumor indications.

South San Francisco, CA – onsite four days per week as required by company policy.

IDEAYA is seeking a talented and highly motivated Associate Director, Quality Management Systems (QMS) to lead the QMS function and oversee all quality systems (GMP, GCP, and GLP), implementation and oversight of EQMS, and corporate quality policies and procedures. The role will strengthen quality systems, determine infrastructure and resources required, and work with functional groups to support the company’s business goals.

• Drive development of the company’s QMS strategy and policies.
• Oversee company‑wide documentation practices, record keeping, training, quality systems, and risk assessment in compliance with internal and external clinical, safety, quality, and regulatory standards.
• Lead implementation and continuous improvement of Veeva Quality Docs, Training, and QMS modules.
• Manage the QMS SME consultants and lead the QMS function.
• Own Document Control, Training, Change Management, Deviation/CAPA, Customer Compliance, and associated quality systems.
• Create, review, and modify Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Develop and oversee robust, phase‑appropriate quality systems to ensure manufacturing and quality control activities comply with current GxP guidelines.
• Implement continuous improvements, develop phase‑appropriate quality metrics, and lead routine Senior Management Review and Annual Product Review.
• Assist with service provider oversight, including qualification, routine audits, and vendor quality management plans.
• Oversee internal and external audits to assess compliance with GxP regulatory requirements and implement corrective actions.
• Ensure inspection readiness and provide guidance during regulatory inspections.
• Collaborate with functional leads on risk assessments for clinical development, manufacturing activities, and service provider oversight.
• Facilitate training on quality systems, policies, and SOPs for employees and GxP contractors.

• BS degree in Biological Science, Engineering, or Operations Management; advanced degree preferred.
• Minimum eight (8) years of experience in biopharmaceutical companies with strong knowledge of all GxP disciplines.
• Successful track record of implementing EQMS, preferably Veeva Quality Docs and QMS or other electronic systems.
• Working knowledge of Veeva workflows and configurations for efficient, compliant improvement projects.
• Deep understanding of contemporary quality practices as applied to product development, clinical manufacturing, and commercial operations.
• Knowledge and ability to apply GxP, FDA, EU, and ICH regulations and guidelines.
• Proven expertise in designing and implementing quality processes.
• Experience fostering an organizational culture that promotes and sustains quality as a core business performance driver.
• Ability to relate quality functions to overall business strategy.
• Results‑oriented team player who enjoys collaboration and building positive relationships.
• Strong independent work ethic and flexibility in a fast‑paced, high‑growth environment.
• Excellent verbal and written communication skills.
• Expectation to act with integrity and full compliance with applicable laws, regulations, and IDEAYA policies, including the Code of Conduct.

IDEAYA offers a competitive total rewards package that includes merit‑based salary increases, discretionary short‑term incentive plan participation, and stock option awards. Benefits include comprehensive medical/dental/vision coverage (100% company paid for employees, 90% for dependents), 401(k), ESPP, and wellness programs.

IDEAYA is an equal‑opportunity employer and complies with all laws respecting equal employment opportunities. We do not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets. We are committed to providing reasonable accommodations to qualified individuals with disabilities. Contact hr@ideayabio.com for assistance or accommodations due to a disability.

All employees working in IDEAYA facilities must be fully vaccinated against COVID‑19, subject to reasonable accommodations for medical or religious reasons. Full vaccination is defined as 14 days after the second dose of a two‑dose series or after a single‑dose vaccine, meeting FDA or WHO approvals. Employees must be fully vaccinated before beginning at‑site work.