BioSpace
Director, Good Manufacturing Practices & Computer System Validation Quality Assu
BioSpace, South San Francisco, California, us, 94083
Overview
Director, Good Manufacturing Practices & Computer System Validation Quality Assurance Location: South San Francisco, CA. This is a leadership role within the IDEAYA Quality team responsible for developing and maintaining GMP and CSV Quality Systems, supporting internal and external compliance activities, and ensuring the highest standards of product quality and patient safety. Reports to the Vice President, Quality. Non-Solicitation Policy And Notice To Agencies And Recruiters IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from contacting IDEAYA employees or submitting unsolicited resumes. All recruiting and talent agency decisions are managed by IDEAYA Human Resources. External agencies and recruiters should direct communications to humanresources@ideayabio.com. Please email your interest only once. We are a precision medicine oncology company focused on small-molecule drug discovery, structural biology, and bioinformatics to develop targeted therapies for cancer. For more information, please see www.ideayabio.com. EEO/AA/Vets. IDEAYA is an equal opportunity employer and does not discriminate on protected characteristics. Position 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 as well as supporting internal and external compliance activities. Responsibilities include Deviation, CAPA, Change Control, and Batch Release systems, acting as QA liaison to project teams, and ensuring compliance with regulatory requirements, industry standards, and company policies for manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). The Director will provide strategic leadership, drive continuous improvement, provide quality oversight of contract organizations, and ensure high standards of product quality and patient safety. This position will report to the Vice President, Quality. This position is based in South San Francisco and is onsite four days per week per company policy. Job Description 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 that cGMP departments and Operating units within Ideaya have written procedures to support GxP activities. Oversee the development, implementation, and maintenance of GMP QA policies, quality agreements, standard operating procedures, and quality systems processes and workflows to manage quality events. Manage and oversee all aspects of GxP quality functions for clinical and commercial products i.e., Lot Release, Quality Systems records (e.g., Deviations, Change Control, Complaints, Audits, Product Quality Review). Monitor emerging regulatory trends and ensure proactive adaptation of QA processes. Compile, track quality metrics (KPI) on process, product attribute and supplier performance and report to management on a quarterly basis. Lead and manage GMP audits programs (internal and external), including manufacturing sites, contract manufacturers and packagers, suppliers, and laboratories. 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. Review and approve audit reports, CAPA plans, and follow-up actions to ensure effective resolution of non-conformance and quality events. Lead or oversee the annual product quality review (APQR) process to ensure ongoing evaluation of product quality and compliance. Drive continuous improvement initiatives based on KPIs, APQR findings and trends. Identify, assess, and mitigate GMP-related risks across the supply chain (end to end), GMP vendors and manufacturing processes. Provide expert guidance on GMP & CSV compliance and escalate critical quality events, nonconformances and compliance issues to cross-functional teams and senior management. Collaborate with manufacturing, supply chain, regulatory affairs, and other stakeholders to address quality issues and drive continuous improvement. Build, mentor, and lead a high-performing GMP & CSV QA team. Foster a culture of quality, accountability, and collaboration within the team and across the organization. Partner with CMC, regulatory affairs, IT and R&D to ensure alignment on quality and compliance objectives. Support the development and review of batch records, specifications, test methods, protocols, and other critical documents. Oversee the selection, qualification, and ongoing monitoring of all GMP vendors, including contract manufacturers, suppliers, and testing laboratories. Ensure vendor compliance with contractual obligations, quality agreements 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 working in a firm with in-house manufacturing. 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. Strong knowledge of global GMP & CSV regulations, ICH guidelines, and pharmaceutical manufacturing processes. Experience hosting regulatory inspections (e.g., FDA, EMA, PMDA) and managing Ideaya audit programs. Exceptional leadership and team-building skills, strong analytical, problem-solving, and decision-making abilities. Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels. Strategic thinker with a focus on continuous improvement and innovation. This role may require occasional travel (up to 20%) for audits, inspections, and meetings. Preferred Skills Prior supervisory or function management experience is required. Total Rewards Along with our inspiring mission, IDEAYA offers a competitive total rewards package that includes merit-based salary increases, discretionary short-term incentive plan participation, and discretionary stock option awards (board approval). Benefits include medical/dental/vision coverage (100% company paid for employees and 90% for dependents), 401k, ESPP, and wellness programs. The expected salary range is $187,000 - $231,000. Final salary depends on location, experience, education, and interview performance. The Company complies with equal employment opportunity laws and does not discriminate. This position requires onsite work with some work-from-home flexibility and vaccination per applicable law. Full vaccination from COVID-19 is required, subject to reasonable accommodations and/or as required by law. EOE/AA/Vets.
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Director, Good Manufacturing Practices & Computer System Validation Quality Assurance Location: South San Francisco, CA. This is a leadership role within the IDEAYA Quality team responsible for developing and maintaining GMP and CSV Quality Systems, supporting internal and external compliance activities, and ensuring the highest standards of product quality and patient safety. Reports to the Vice President, Quality. Non-Solicitation Policy And Notice To Agencies And Recruiters IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from contacting IDEAYA employees or submitting unsolicited resumes. All recruiting and talent agency decisions are managed by IDEAYA Human Resources. External agencies and recruiters should direct communications to humanresources@ideayabio.com. Please email your interest only once. We are a precision medicine oncology company focused on small-molecule drug discovery, structural biology, and bioinformatics to develop targeted therapies for cancer. For more information, please see www.ideayabio.com. EEO/AA/Vets. IDEAYA is an equal opportunity employer and does not discriminate on protected characteristics. Position 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 as well as supporting internal and external compliance activities. Responsibilities include Deviation, CAPA, Change Control, and Batch Release systems, acting as QA liaison to project teams, and ensuring compliance with regulatory requirements, industry standards, and company policies for manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). The Director will provide strategic leadership, drive continuous improvement, provide quality oversight of contract organizations, and ensure high standards of product quality and patient safety. This position will report to the Vice President, Quality. This position is based in South San Francisco and is onsite four days per week per company policy. Job Description 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 that cGMP departments and Operating units within Ideaya have written procedures to support GxP activities. Oversee the development, implementation, and maintenance of GMP QA policies, quality agreements, standard operating procedures, and quality systems processes and workflows to manage quality events. Manage and oversee all aspects of GxP quality functions for clinical and commercial products i.e., Lot Release, Quality Systems records (e.g., Deviations, Change Control, Complaints, Audits, Product Quality Review). Monitor emerging regulatory trends and ensure proactive adaptation of QA processes. Compile, track quality metrics (KPI) on process, product attribute and supplier performance and report to management on a quarterly basis. Lead and manage GMP audits programs (internal and external), including manufacturing sites, contract manufacturers and packagers, suppliers, and laboratories. 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. Review and approve audit reports, CAPA plans, and follow-up actions to ensure effective resolution of non-conformance and quality events. Lead or oversee the annual product quality review (APQR) process to ensure ongoing evaluation of product quality and compliance. Drive continuous improvement initiatives based on KPIs, APQR findings and trends. Identify, assess, and mitigate GMP-related risks across the supply chain (end to end), GMP vendors and manufacturing processes. Provide expert guidance on GMP & CSV compliance and escalate critical quality events, nonconformances and compliance issues to cross-functional teams and senior management. Collaborate with manufacturing, supply chain, regulatory affairs, and other stakeholders to address quality issues and drive continuous improvement. Build, mentor, and lead a high-performing GMP & CSV QA team. Foster a culture of quality, accountability, and collaboration within the team and across the organization. Partner with CMC, regulatory affairs, IT and R&D to ensure alignment on quality and compliance objectives. Support the development and review of batch records, specifications, test methods, protocols, and other critical documents. Oversee the selection, qualification, and ongoing monitoring of all GMP vendors, including contract manufacturers, suppliers, and testing laboratories. Ensure vendor compliance with contractual obligations, quality agreements 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 working in a firm with in-house manufacturing. 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. Strong knowledge of global GMP & CSV regulations, ICH guidelines, and pharmaceutical manufacturing processes. Experience hosting regulatory inspections (e.g., FDA, EMA, PMDA) and managing Ideaya audit programs. Exceptional leadership and team-building skills, strong analytical, problem-solving, and decision-making abilities. Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels. Strategic thinker with a focus on continuous improvement and innovation. This role may require occasional travel (up to 20%) for audits, inspections, and meetings. Preferred Skills Prior supervisory or function management experience is required. Total Rewards Along with our inspiring mission, IDEAYA offers a competitive total rewards package that includes merit-based salary increases, discretionary short-term incentive plan participation, and discretionary stock option awards (board approval). Benefits include medical/dental/vision coverage (100% company paid for employees and 90% for dependents), 401k, ESPP, and wellness programs. The expected salary range is $187,000 - $231,000. Final salary depends on location, experience, education, and interview performance. The Company complies with equal employment opportunity laws and does not discriminate. This position requires onsite work with some work-from-home flexibility and vaccination per applicable law. Full vaccination from COVID-19 is required, subject to reasonable accommodations and/or as required by law. EOE/AA/Vets.
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