IDEAYA Biosciences
Director, Good Manufacturing Practices & Computer System Validation Quality Assu
IDEAYA Biosciences, South San Francisco, California, us, 94083
Overview
Director, Good Manufacturing Practices & Computer System Validation Quality Assurance – IDEAYA Biosciences Location: South San Francisco, CA. Onsite four days per week per company policy. Job Summary
We are seeking a 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 acting as QA liaison to project teams. The role ensures compliance with regulatory requirements, industry standards, and company policies for the manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). The Director will provide strategic leadership, drive continuous improvement, oversee contract organizations, and ensure high standards of product quality and patient safety. This position reports to the Vice President, Quality. This position is based in South San Francisco and is onsite four days per week. What you’ll do
Develop and implement the global GMP & CSV QA strategy aligned with corporate goals, IDEAYA SOPs and global regulatory requirements. Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards. Develop procedures and workflows to define key Quality Systems including Deviation, CAPA, Change Control and Document management. Ensure written procedures support GxP activities. Oversee the development, implementation, and maintenance of 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, Quality Systems records such as 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 sites, contract manufacturers, suppliers, and laboratories. Host and support regulatory inspections, ensuring readiness and timely resolution of findings. Represent QA in regulatory inspections and due diligence activities. Review and approve audit reports, CAPA plans, and follow-up actions to resolve non-conformances. Lead or oversee the annual product quality review (APQR) process and drive continuous improvement initiatives from KPIs 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, IT, and R&D to address quality issues and drive improvement. Build, mentor, and lead a high-performing GMP & CSV QA team and foster a culture of quality and accountability. Support the development and review of batch records, specifications, test methods, protocols, and other critical documents. Oversee vendor qualification and monitoring of GMP vendors, including contract manufacturers, suppliers, and testing laboratories. Ensure vendor compliance with contractual obligations and regulatory requirements. Requirements
Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred). Minimum of 12 years of experience in the pharmaceutical or biotechnology industry, with at least 8 years in GMP QA or manufacturing quality roles 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 with evolving priorities. Strong knowledge of global GMP & CSV regulations, ICH guidelines, and pharmaceutical manufacturing processes. Experience hosting regulatory inspections (FDA, EMA, PMDA) and managing IDEAYA audit programs. Exceptional leadership, analytical, problem-solving, and decision-making skills; excellent communication and interpersonal abilities. Strategic thinker with a focus on continuous improvement and innovation. Travel: up to 20% for audits, inspections, and meetings (as needed). Preferred Skills
Prior supervisory or function management experience is required. Total Rewards
IDEAYA offers a competitive total rewards package with merit-based salary increases, discretionary short-term incentive participation, and discretionary stock option awards (board approval). Benefits include medical/dental/vision coverage (100% company paid for employees, 90% for dependents), 401k, ESPP, and wellness programs. The expected salary range is $187,000 - $231,000, with final offer dependent on location, experience, education, and interview performance. The Company is an equal opportunity employer and complies with applicable laws prohibiting discrimination. This position requires onsite work with COVID-19 vaccination unless a reasonable accommodation applies and as required by law. Company Information
IDEAYA is a precision medicine oncology company focused on discovery, development, and commercialization of targeted therapies for cancer, combining small-molecule drug discovery, structural biology, and bioinformatics with translational biomarker validation. For more information, please see www.ideayabio.com.
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Director, Good Manufacturing Practices & Computer System Validation Quality Assurance – IDEAYA Biosciences Location: South San Francisco, CA. Onsite four days per week per company policy. Job Summary
We are seeking a 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 acting as QA liaison to project teams. The role ensures compliance with regulatory requirements, industry standards, and company policies for the manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). The Director will provide strategic leadership, drive continuous improvement, oversee contract organizations, and ensure high standards of product quality and patient safety. This position reports to the Vice President, Quality. This position is based in South San Francisco and is onsite four days per week. What you’ll do
Develop and implement the global GMP & CSV QA strategy aligned with corporate goals, IDEAYA SOPs and global regulatory requirements. Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards. Develop procedures and workflows to define key Quality Systems including Deviation, CAPA, Change Control and Document management. Ensure written procedures support GxP activities. Oversee the development, implementation, and maintenance of 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, Quality Systems records such as 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 sites, contract manufacturers, suppliers, and laboratories. Host and support regulatory inspections, ensuring readiness and timely resolution of findings. Represent QA in regulatory inspections and due diligence activities. Review and approve audit reports, CAPA plans, and follow-up actions to resolve non-conformances. Lead or oversee the annual product quality review (APQR) process and drive continuous improvement initiatives from KPIs 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, IT, and R&D to address quality issues and drive improvement. Build, mentor, and lead a high-performing GMP & CSV QA team and foster a culture of quality and accountability. Support the development and review of batch records, specifications, test methods, protocols, and other critical documents. Oversee vendor qualification and monitoring of GMP vendors, including contract manufacturers, suppliers, and testing laboratories. Ensure vendor compliance with contractual obligations and regulatory requirements. Requirements
Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred). Minimum of 12 years of experience in the pharmaceutical or biotechnology industry, with at least 8 years in GMP QA or manufacturing quality roles 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 with evolving priorities. Strong knowledge of global GMP & CSV regulations, ICH guidelines, and pharmaceutical manufacturing processes. Experience hosting regulatory inspections (FDA, EMA, PMDA) and managing IDEAYA audit programs. Exceptional leadership, analytical, problem-solving, and decision-making skills; excellent communication and interpersonal abilities. Strategic thinker with a focus on continuous improvement and innovation. Travel: up to 20% for audits, inspections, and meetings (as needed). Preferred Skills
Prior supervisory or function management experience is required. Total Rewards
IDEAYA offers a competitive total rewards package with merit-based salary increases, discretionary short-term incentive participation, and discretionary stock option awards (board approval). Benefits include medical/dental/vision coverage (100% company paid for employees, 90% for dependents), 401k, ESPP, and wellness programs. The expected salary range is $187,000 - $231,000, with final offer dependent on location, experience, education, and interview performance. The Company is an equal opportunity employer and complies with applicable laws prohibiting discrimination. This position requires onsite work with COVID-19 vaccination unless a reasonable accommodation applies and as required by law. Company Information
IDEAYA is a precision medicine oncology company focused on discovery, development, and commercialization of targeted therapies for cancer, combining small-molecule drug discovery, structural biology, and bioinformatics with translational biomarker validation. For more information, please see www.ideayabio.com.
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