Global GCP QA Director & Compliance Leader

Structure Therapeutics, Inc.; South San Francisco (CA); Hybrid; USD 165,000 - 210,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Unlimited PTO

Job summary

Structure Therapeutics, Inc. is seeking an Associate Director, Global GCP QA to lead quality oversight of clinical programs and ensure compliance with global regulations including FDA/EMA/GCP.

The role collaborates cross-functionally to drive continuous improvement, risk management, and data integrity across programs, including China operations. The position requires 8+ years in pharma/biotech with 4+ years in GCP QA lead auditing, and familiarity with ICH GCP standards.

Qualifications

• BS/MS or equivalent in a scientific discipline required; advanced degree is preferred.
• Auditor certifications and/or SQA RQAP credentials are preferred.
• 8+ years of pharmaceutical/biotechnology experience, including at least 4 years in GCP QA lead auditor role.
• Prior experience in Big Pharma is preferred.
• Prior experience in supporting regulatory inspections (FDA, EMA, MHRA, NMPA, PMDA).
• Expertise in ICH E6, E8, E2A-F, 21 CFR Part 11, EU Annex 11, and other global standards.
• Working knowledge of EDMS and other document and data management platforms.

Responsibilities

• Provide QA oversight for assigned clinical programs.
• Ensure compliance with health authority regulations and guidelines.
• Review key Clinical and regulatory submission documents.
• Identify risks with vendors and support study compliance.
• Review trial documentation for data integrity and GCP compliance.
• Manage quality events and CAPAs; escalate significant risks.
• Prepare quality metrics and trend analyses for leadership.
• Develop and maintain quality SOPs and templates to support GCP QMS.

Skills

GCP QA leadership

Auditing

Regulatory inspections

Quality systems

Project management

Communication

Education

BS/MS or equivalent

Advanced degree preferred

Tools

EDMS

Document management systems

Job description

Structure Therapeutics, Inc. is seeking an Associate Director, Global GCP QA to lead quality oversight of clinical programs and ensure compliance with global regulations including FDA/EMA/GCP.

The role collaborates cross-functionally to drive continuous improvement, risk management, and data integrity across programs, including China operations. The position requires 8+ years in pharma/biotech with 4+ years in GCP QA lead auditing, and familiarity with ICH GCP standards.