BioSpace, Inc.
Director, Good Manufacturing Practices & Computer System Validation Quality Assu
BioSpace, Inc., South San Francisco, California, us, 94083
Overview
We are seeking a Director of Good Manufacturing Practices and Computer System Validation Quality Assurance to join our IDEAYA Quality team. The Director is a leadership role responsible for developing and maintaining GMP and CSV Quality Systems and supporting internal and external compliance activities. Direct responsibility for the Deviation, CAPA, Change Control, and Batch Release Systems. The Director will provide QA liaison support to various project teams and ensure compliance with regulatory requirements, industry standards, and company policies for the manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). This position reports to the Vice President, Quality. Location: South San Francisco, CA. Onsite four days per week. What youll 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 (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, 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 (Deviations, Change Control, Complaints, Audits, APQR). Monitor emerging regulatory trends and ensure proactive adaptation of QA processes. Compile and track quality metrics (KPI) on process, product attribute and supplier performance and report to management on a quarterly basis. Lead and manage GMP audit 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 KPI data, 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, IT and R&D 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 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 (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
IDEAYA offers a competitive total rewards package including merit-based salary increases, discretionary short-term incentive plan participation, and discretionary stock option awards (board approval). Our benefits package includes medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs. The expected salary range is $187,000 - $231,000. The final salary depends on location, experience, and interview performance. Equal Employment Opportunity
The Company complies with all laws respecting equal employment opportunities and does not discriminate based on protected characteristics. EOE/AA/Vets. Onsite work in facilities; vaccines required subject to applicable law. This position requires that you be fully vaccinated from COVID-19, subject to reasonable accommodations and/or as required by law. The vaccine must have been FDA-approved, have EUA status from FDA, or be listed for emergency use by WHO for international candidates. #J-18808-Ljbffr
We are seeking a Director of Good Manufacturing Practices and Computer System Validation Quality Assurance to join our IDEAYA Quality team. The Director is a leadership role responsible for developing and maintaining GMP and CSV Quality Systems and supporting internal and external compliance activities. Direct responsibility for the Deviation, CAPA, Change Control, and Batch Release Systems. The Director will provide QA liaison support to various project teams and ensure compliance with regulatory requirements, industry standards, and company policies for the manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). This position reports to the Vice President, Quality. Location: South San Francisco, CA. Onsite four days per week. What youll 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 (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, 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 (Deviations, Change Control, Complaints, Audits, APQR). Monitor emerging regulatory trends and ensure proactive adaptation of QA processes. Compile and track quality metrics (KPI) on process, product attribute and supplier performance and report to management on a quarterly basis. Lead and manage GMP audit 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 KPI data, 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, IT and R&D 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 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 (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
IDEAYA offers a competitive total rewards package including merit-based salary increases, discretionary short-term incentive plan participation, and discretionary stock option awards (board approval). Our benefits package includes medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs. The expected salary range is $187,000 - $231,000. The final salary depends on location, experience, and interview performance. Equal Employment Opportunity
The Company complies with all laws respecting equal employment opportunities and does not discriminate based on protected characteristics. EOE/AA/Vets. Onsite work in facilities; vaccines required subject to applicable law. This position requires that you be fully vaccinated from COVID-19, subject to reasonable accommodations and/or as required by law. The vaccine must have been FDA-approved, have EUA status from FDA, or be listed for emergency use by WHO for international candidates. #J-18808-Ljbffr