Senior Director, Global GMP Quality Assurance
Structure Therapeutics
August 13, 2026
Remote friendly (South San Francisco, CA)
United States
Operations
Position Summary
We are seeking a Senior Director of GMP Quality Assurance (QA) responsible for developing, leading, and executing the global GMP QA strategy to support transition from clinical development to commercial readiness.
Job Responsibilities
- Serve as functional leader for GLP/GMP Quality Assurance and Quality Leadership Team member; oversee quality activities across nonclinical, clinical, and manufacturing.
- Lead, develop, and manage GLP/GMP Quality Assurance and QC Compliance teams; build a culture of quality and continuous improvement.
- Develop and execute GLP/GMP Quality strategy; establish a quality vision that supports compliance, inspection readiness, scalability, and growth.
- Oversee Quality Management System processes: deviations, investigations, CAPAs, change controls, complaints, product disposition, supplier quality management, and quality risk management.
- Ensure compliance with GLP/GMP and applicable regulatory standards (FDA, EMA, ICH, OECD, NMPA, etc.).
- Provide quality oversight for GLP nonclinical activities (toxicology, pharmacology, DMPK, bioanalytical, outsourced preclinical).
- Provide quality oversight for GMP manufacturing/testing/supply (clinical and commercial).
- Oversee QC Compliance: lab investigations, OOS/OOT, data integrity, analytical method lifecycle, computerized systems, inspection readiness.
- Lead internal/regulatory/sponsor/customer audit preparedness.
- Oversee external partners (CROs, CMOs, CDMOs, contract labs) via quality agreements, governance, escalation, and performance metrics.
- Apply risk-based decision-making and provide quality guidance/recommendations to leadership.
- Lead Quality Management Review meetings using metrics, trends, audit outcomes, and risk assessments.
Qualifications
- Bachelor’s in relevant scientific field required; Master’s/Ph.D. preferred.
- 15+ years GLP/GMP quality management experience in manufacturing/lab or pharma.
- Proven leadership in building and leading high-performing teams.
- In-depth GLP/GMP regulatory knowledge.
- Strong analytical/problem-solving, communication/interpersonal, and organizational skills; attention to detail.
- Quality Management certification is a plus.
Travel Required: 10–20%
Benefits
- Annual performance incentive bonus; new hire equity and ongoing performance-based equity.
- Medical, dental, vision, 401k match, unlimited PTO, paid holidays including winter shutdown.
Application Instructions
- Apply through the official career page at BambooHR.
We are seeking a Senior Director of GMP Quality Assurance (QA) responsible for developing, leading, and executing the global GMP QA strategy to support transition from clinical development to commercial readiness.
Job Responsibilities
- Serve as functional leader for GLP/GMP Quality Assurance and Quality Leadership Team member; oversee quality activities across nonclinical, clinical, and manufacturing.
- Lead, develop, and manage GLP/GMP Quality Assurance and QC Compliance teams; build a culture of quality and continuous improvement.
- Develop and execute GLP/GMP Quality strategy; establish a quality vision that supports compliance, inspection readiness, scalability, and growth.
- Oversee Quality Management System processes: deviations, investigations, CAPAs, change controls, complaints, product disposition, supplier quality management, and quality risk management.
- Ensure compliance with GLP/GMP and applicable regulatory standards (FDA, EMA, ICH, OECD, NMPA, etc.).
- Provide quality oversight for GLP nonclinical activities (toxicology, pharmacology, DMPK, bioanalytical, outsourced preclinical).
- Provide quality oversight for GMP manufacturing/testing/supply (clinical and commercial).
- Oversee QC Compliance: lab investigations, OOS/OOT, data integrity, analytical method lifecycle, computerized systems, inspection readiness.
- Lead internal/regulatory/sponsor/customer audit preparedness.
- Oversee external partners (CROs, CMOs, CDMOs, contract labs) via quality agreements, governance, escalation, and performance metrics.
- Apply risk-based decision-making and provide quality guidance/recommendations to leadership.
- Lead Quality Management Review meetings using metrics, trends, audit outcomes, and risk assessments.
Qualifications
- Bachelor’s in relevant scientific field required; Master’s/Ph.D. preferred.
- 15+ years GLP/GMP quality management experience in manufacturing/lab or pharma.
- Proven leadership in building and leading high-performing teams.
- In-depth GLP/GMP regulatory knowledge.
- Strong analytical/problem-solving, communication/interpersonal, and organizational skills; attention to detail.
- Quality Management certification is a plus.
Travel Required: 10–20%
Benefits
- Annual performance incentive bonus; new hire equity and ongoing performance-based equity.
- Medical, dental, vision, 401k match, unlimited PTO, paid holidays including winter shutdown.
Application Instructions
- Apply through the official career page at BambooHR.