Senior Director, Global GMP Quality Assurance
Structure Therapeutics
June 30, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
Position Summary
Senior Director of GMP Quality Assurance (QA) responsible for developing, leading, and executing the global GMP QA strategy to support the transition from clinical development to commercial readiness. Verifies compliance with cGMP regulations, company policies/procedures, and industry standards; provides quality leadership across GLP/GMP operations and serves as a trusted advisor on GMP QA risk management.
Job Responsibilities
- Lead GLP/GMP Quality Assurance and provide strategic oversight across nonclinical, clinical, and manufacturing operations.
- Lead, develop, and manage GLP/GMP QA and QC Compliance teams; build and scale a high-performing quality organization.
- Develop/execute GLP/GMP Quality strategy and establish a quality vision for compliance, inspection readiness, operational excellence, and scalability.
- Oversee QMS processes: deviations, investigations, CAPAs, change controls, complaints, product disposition, supplier quality management, and quality risk management.
- Ensure compliance with GLP, GMP, FDA, EMA, ICH, OECD, NMPA, and other applicable regulatory requirements.
- Provide quality oversight of GLP-regulated nonclinical activities and GMP manufacturing/testing/supply (clinical and commercial).
- Oversee QC Compliance: laboratory investigations, OOS/OOT, data integrity, analytical method lifecycle compliance, laboratory computerized systems, and inspection readiness.
- Lead preparedness for internal audits, regulatory inspections, sponsor audits, and customer audits.
- Oversee external partners (CROs, CMOs, CDMOs, contract labs) via quality agreements, governance/oversight models, escalation, and performance metrics.
- Lead Quality Management Review meetings using quality metrics, compliance trends, audit outcomes, and risk assessments.
Qualifications
- Bachelor’s degree in a relevant scientific field (Master’s or Ph.D. preferred).
- 15+ years of GLP/GMP quality management experience in manufacturing/laboratory or pharmaceutical settings.
- Proven leadership building high-performing teams.
- In-depth knowledge of GLP/GMP regulations and best practices.
- Strong analytical/problem-solving, communication, collaboration, and organizational skills.
- Quality Management certification is a plus.
Preferred/Required Skills
- Risk-based decision-making and sound judgment.
Benefits (if applicable)
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity.
- Medical, dental, vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown.
Application Instructions
Apply through the official career page at BambooHR.
Travel
- 10–20% travel
Senior Director of GMP Quality Assurance (QA) responsible for developing, leading, and executing the global GMP QA strategy to support the transition from clinical development to commercial readiness. Verifies compliance with cGMP regulations, company policies/procedures, and industry standards; provides quality leadership across GLP/GMP operations and serves as a trusted advisor on GMP QA risk management.
Job Responsibilities
- Lead GLP/GMP Quality Assurance and provide strategic oversight across nonclinical, clinical, and manufacturing operations.
- Lead, develop, and manage GLP/GMP QA and QC Compliance teams; build and scale a high-performing quality organization.
- Develop/execute GLP/GMP Quality strategy and establish a quality vision for compliance, inspection readiness, operational excellence, and scalability.
- Oversee QMS processes: deviations, investigations, CAPAs, change controls, complaints, product disposition, supplier quality management, and quality risk management.
- Ensure compliance with GLP, GMP, FDA, EMA, ICH, OECD, NMPA, and other applicable regulatory requirements.
- Provide quality oversight of GLP-regulated nonclinical activities and GMP manufacturing/testing/supply (clinical and commercial).
- Oversee QC Compliance: laboratory investigations, OOS/OOT, data integrity, analytical method lifecycle compliance, laboratory computerized systems, and inspection readiness.
- Lead preparedness for internal audits, regulatory inspections, sponsor audits, and customer audits.
- Oversee external partners (CROs, CMOs, CDMOs, contract labs) via quality agreements, governance/oversight models, escalation, and performance metrics.
- Lead Quality Management Review meetings using quality metrics, compliance trends, audit outcomes, and risk assessments.
Qualifications
- Bachelor’s degree in a relevant scientific field (Master’s or Ph.D. preferred).
- 15+ years of GLP/GMP quality management experience in manufacturing/laboratory or pharmaceutical settings.
- Proven leadership building high-performing teams.
- In-depth knowledge of GLP/GMP regulations and best practices.
- Strong analytical/problem-solving, communication, collaboration, and organizational skills.
- Quality Management certification is a plus.
Preferred/Required Skills
- Risk-based decision-making and sound judgment.
Benefits (if applicable)
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity.
- Medical, dental, vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown.
Application Instructions
Apply through the official career page at BambooHR.
Travel
- 10–20% travel