BioSpace
Director, Good Manufacturing Practices & Computer System Validation Quality Assu
BioSpace, South San Francisco, California, us, 94083
Director, Good Manufacturing Practices & Computer System Validation Quality Assurance
IDEAYA Biosciences is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our focus includes synthetic lethality and antibody‑drug conjugates for molecularly defined solid tumor indications. The company operates from South San Francisco, CA.
Position Summary The Director of GMP & CSV QA leads the development and maintenance of Good Manufacturing Practices (GMP) and Computer System Validation (CSV) quality systems, ensuring compliance with regulatory requirements and industry standards. The role reports to the Vice President, Quality and is based onsite at our South San Francisco headquarters, requiring presence four days per week.
Job Description – Responsibilities
Develop and implement the global GMP & CSV QA strategy aligned with corporate goals and regulatory requirements.
Ensure compliance with global GMP regulations (FDA, EMA, PMDA, ICH Q7, Q10) and company standards.
Design procedures and workflows for Deviation, CAPA, Change Control, and Document management.
Oversee GMP QA policies, quality agreements, SOPs, and processes for quality events.
Manage GxP quality functions for clinical and commercial products, including Lot Release and quality records.
Monitor emerging regulatory trends and adapt QA processes proactively.
Track quality metrics (KPI) and report to management quarterly.
Lead and manage GMP audit programs (internal and external) with manufacturing sites, contract manufacturers, and suppliers.
Host and support regulatory inspections, ensuring inspection readiness and resolution of findings.
Review audit reports, CAPA plans, and follow‑ups to ensure effective resolution of non‑conformances.
Lead or oversee the annual product quality review (APQR) process.
Drive continuous improvement initiatives based on KPIs and APQR findings.
Identify, assess, and mitigate GMP‑related risks across the supply chain and vendors.
Escalate critical quality events to cross‑functional teams and senior management.
Collaborate with manufacturing, supply chain, regulatory affairs, IT, and R&D to address quality issues.
Build, mentor, and lead a high‑performing GMP & CSV QA team.
Partner with CMC, regulatory affairs, IT, and R&D to ensure alignment on quality objectives.
Support development and review of batch records, specifications, test methods, protocols, and critical documents.
Oversee qualification and ongoing monitoring of all GMP vendors, ensuring compliance with contractual obligations.
Requirements
Advanced degree in life sciences, pharmacy, chemistry, or related field (PhD, MS, or equivalent preferred).
Minimum 12 years of pharmaceutical or biotechnology industry experience, with at least 8 years in GMP QA or manufacturing quality roles in an in‑house manufacturing environment.
Proven track record leading GMP QA functions within a global organization.
Strong knowledge of global GMP & CSV regulations, ICH guidelines, and pharmaceutical manufacturing processes.
Experience hosting regulatory inspections (FDA, EMA, PMDA) and managing audit programs.
Exceptional leadership and team‑building skills, analytical and problem‑solving abilities.
Excellent communication and stakeholder influence at all levels.
Strategic thinker focused on continuous improvement and innovation.
Occasional travel (up to 20%) for audits, inspections, and meetings.
Preferred Skills
Prior supervisory or function management experience.
Benefits and Compensation Competitive salary range: $187,000 – $231,000. Total rewards include medical/dental/vision coverage, 401(k), ESPP, wellness programs, and performance‑based incentives. The full package aligns with IDEAYA’s pay‑for‑performance philosophy.
Equal Opportunity Statement IDEAYA complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires onsite work and a fully vaccinated status unless an accommodation is granted. IDEAYA is an equal‑opportunity employer. EOE/AA/Vets.
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Position Summary The Director of GMP & CSV QA leads the development and maintenance of Good Manufacturing Practices (GMP) and Computer System Validation (CSV) quality systems, ensuring compliance with regulatory requirements and industry standards. The role reports to the Vice President, Quality and is based onsite at our South San Francisco headquarters, requiring presence four days per week.
Job Description – Responsibilities
Develop and implement the global GMP & CSV QA strategy aligned with corporate goals and regulatory requirements.
Ensure compliance with global GMP regulations (FDA, EMA, PMDA, ICH Q7, Q10) and company standards.
Design procedures and workflows for Deviation, CAPA, Change Control, and Document management.
Oversee GMP QA policies, quality agreements, SOPs, and processes for quality events.
Manage GxP quality functions for clinical and commercial products, including Lot Release and quality records.
Monitor emerging regulatory trends and adapt QA processes proactively.
Track quality metrics (KPI) and report to management quarterly.
Lead and manage GMP audit programs (internal and external) with manufacturing sites, contract manufacturers, and suppliers.
Host and support regulatory inspections, ensuring inspection readiness and resolution of findings.
Review audit reports, CAPA plans, and follow‑ups to ensure effective resolution of non‑conformances.
Lead or oversee the annual product quality review (APQR) process.
Drive continuous improvement initiatives based on KPIs and APQR findings.
Identify, assess, and mitigate GMP‑related risks across the supply chain and vendors.
Escalate critical quality events to cross‑functional teams and senior management.
Collaborate with manufacturing, supply chain, regulatory affairs, IT, and R&D to address quality issues.
Build, mentor, and lead a high‑performing GMP & CSV QA team.
Partner with CMC, regulatory affairs, IT, and R&D to ensure alignment on quality objectives.
Support development and review of batch records, specifications, test methods, protocols, and critical documents.
Oversee qualification and ongoing monitoring of all GMP vendors, ensuring compliance with contractual obligations.
Requirements
Advanced degree in life sciences, pharmacy, chemistry, or related field (PhD, MS, or equivalent preferred).
Minimum 12 years of pharmaceutical or biotechnology industry experience, with at least 8 years in GMP QA or manufacturing quality roles in an in‑house manufacturing environment.
Proven track record leading GMP QA functions within a global organization.
Strong knowledge of global GMP & CSV regulations, ICH guidelines, and pharmaceutical manufacturing processes.
Experience hosting regulatory inspections (FDA, EMA, PMDA) and managing audit programs.
Exceptional leadership and team‑building skills, analytical and problem‑solving abilities.
Excellent communication and stakeholder influence at all levels.
Strategic thinker focused on continuous improvement and innovation.
Occasional travel (up to 20%) for audits, inspections, and meetings.
Preferred Skills
Prior supervisory or function management experience.
Benefits and Compensation Competitive salary range: $187,000 – $231,000. Total rewards include medical/dental/vision coverage, 401(k), ESPP, wellness programs, and performance‑based incentives. The full package aligns with IDEAYA’s pay‑for‑performance philosophy.
Equal Opportunity Statement IDEAYA complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires onsite work and a fully vaccinated status unless an accommodation is granted. IDEAYA is an equal‑opportunity employer. EOE/AA/Vets.
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