Global GCP QA Lead - Remote/Hybrid

Socket.dev; United States; Remote; USD 165,000 - 210,000; Full time

Benefits offered by this job

Annual bonus

New hire equity

Equity

Medical insurance

Dental insurance

Vision insurance

401k match

Unlimited PTO

Paid holidays

Job summary

Structure Therapeutics is seeking an Associate Director, Global GCP QA to lead quality oversight across clinical studies and vendor programs, ensuring compliance with FDA/EMA/NMPA and ICH GCP standards. You will drive CAPAs, metrics and continuous improvement while partnering with clinical teams to safeguard patient safety and data integrity.

The role reports to the Executive Director, Global GCP, QA and offers remote/hybrid work with up to 50% travel, competitive base pay of $165k–$210k, plus

Qualifications

• BS/MS or equivalent in a scientific discipline required; advanced degree preferred.
• Auditor certifications and/or SQA RQAP credentials preferred.
• 8+ years in pharma/biotech with at least 4 years in a GCP QA lead auditor role.
• Experience in Big Pharma preferred.
• Experience supporting regulatory inspections (FDA, EMA, MHRA, NMPA, PMDA).
• Expertise in ICH E6/E8/E2A-F, 21 CFR Part 11, EU Annex 11 and global standards.
• Proven success in executing QMS systems, vendor management and system implementation.

Responsibilities

• Provide QA oversight for assigned clinical programs.
• Ensure compliance of clinical phases and China programs with health authority regulations.
• Review key IND/NDA documents and vendor risk documentation.
• Manage quality events and CAPAs with escalation when needed.
• Prepare quality metrics and drive continuous improvement of GCP processes.
• Lead audits of studies, sites, vendors/CROs, TMFs and CSRs.
• Support inspection readiness and respond to regulatory inquiries.
• Collaborate with clinical functions to implement fit-for-purpose GCP procedures.

Skills

QA governance

GCP/ICH

Regulatory inspections

Audit leadership

Quality metrics

Project management

Cross-functional collaboration

Education

BS/MS or equivalent in science

Advanced degree preferred

Tools

EDMS

QMS systems

Job description

Structure Therapeutics is seeking an Associate Director, Global GCP QA to lead quality oversight across clinical studies and vendor programs, ensuring compliance with FDA/EMA/NMPA and ICH GCP standards. You will drive CAPAs, metrics and continuous improvement while partnering with clinical teams to safeguard patient safety and data integrity.

The role reports to the Executive Director, Global GCP, QA and offers remote/hybrid work with up to 50% travel, competitive base pay of $165k–$210k, plus