Associate Director, Global GCP QA (Remote)

Structure Therapeutics Inc.; Northern (KY); Hybrid; USD 165,000 - 210,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Unlimited PTO

Paid holidays

Job summary

Structure Therapeutics Inc. is seeking an Associate Director, Global GCP QA to provide compliance oversight across clinical studies and vendor programs in line with global standards. Reporting to the Executive Director, Global GCP, QA, you will guide cross-functional teams to maintain data integrity and patient safety.

The role entails leading audits, driving CAPAs, and advancing the GCP QMS. Up to 50% travel; remote or onsite with hybrid options.

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.

Responsibilities

• Lead audits for the assigned studies, including internal processes, investigator sites, vendors/CROs, TMFs, and CSRs (both routine and for-cause).
• Review and interpret audit findings and ensure effective root cause analysis and CAPAs.
• Support GCP-related vendor qualification and oversight, ensuring adherence to global quality standards, contracts and quality agreements.
• Evaluate and mitigate compliance risks in GCP domain with a focus on risk-based thinking and operational efficiency.

Skills

Auditing

GCP QA

Regulatory compliance

Project management

Communication

Education

BS/MS in scientific discipline

Advanced degree preferred

Tools

EDMS

Document management platforms

Job description

Structure Therapeutics Inc. is seeking an Associate Director, Global GCP QA to provide compliance oversight across clinical studies and vendor programs in line with global standards. Reporting to the Executive Director, Global GCP, QA, you will guide cross-functional teams to maintain data integrity and patient safety.

The role entails leading audits, driving CAPAs, and advancing the GCP QMS. Up to 50% travel; remote or onsite with hybrid options.