Remote Global GCP QA Director

Structure Therapeutics Inc.; Northern (KY); Hybrid; USD 225,000 - 285,000; Full time

Benefits offered by this job

Annual bonus

Equity

Medical insurance

Dental insurance

Vision insurance

401k match

Unlimited PTO

Paid holidays

Job summary

Structure Therapeutics Inc. is seeking a Director, Global GCP QA to drive governance, compliance oversight, and strategic execution across clinical studies and vendor programs.

You will lead GCP guidance globally, ensure adherence to ICH GCP and FDA/EMA standards, and collaborate with cross‑functional teams to improve quality systems and patient safety. The role reports to the Executive Director, Global GCP QA, with travel up to 50% and the option to work remote or onsite in a hybrid model.

Qualifications

• BS/MS or equivalent in a scientific discipline required; advanced degree preferred.
• 10+ years of pharmaceutical/biotechnology experience, including at least 7+ years in GCP QA lead auditor role.

Responsibilities

• Lead GCP QA audits and oversee vendor qualification and oversight.
• Lead sponsor inspection readiness and regulatory inspection activities.
• Develop strategies and execute audits for studies, processes, vendors, TMFs, and CSRs.

Skills

GCP QA experience

Auditing leadership

Regulatory inspections

Written and verbal communication

Cross-functional collaboration

Project management

Education

BS/MS in scientific discipline

Tools

EDMS

Quality Management System (QMS)

Regulatory databases

Job description

Structure Therapeutics Inc. is seeking a Director, Global GCP QA to drive governance, compliance oversight, and strategic execution across clinical studies and vendor programs.

You will lead GCP guidance globally, ensure adherence to ICH GCP and FDA/EMA standards, and collaborate with cross‑functional teams to improve quality systems and patient safety. The role reports to the Executive Director, Global GCP QA, with travel up to 50% and the option to work remote or onsite in a hybrid model.