Director, Global GCP QA

Structure Therapeutics

4h•$225,000 - $285,000•Hybrid

About The Position

The Director, Global GCP QA is responsible for governance, compliance oversight, and supporting strategic execution across clinical studies and vendor programs, in compliance with applicable national and international standards, regulations, and guidelines. The position will provide support and promote collaboration internally to ensure all systems; processes, and their outcomes remain compliant. The role will provide expert GCP guidance across global regulatory requirements (FDA, EMA, MHRA, NMPA, PMDA, etc.) and ensure compliance with ICH GCP, FDA, EMA, and other relevant global regulations. The role will collaborate cross-functionally to drive continuous improvement and ensure patient safety and data integrity. This position will report to the Executive Director, Global GCP, QA.

Requirements

BS/MS or equivalent in a scientific discipline required; advanced degree is preferred.
10+ years of pharmaceutical/biotechnology experience, including at least 7+ years in GCP QA lead auditor role.
Proven leadership 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.
Prior success in designing and executing QMS systems, including vendor management and system implementation.
Working knowledge of EDMS and other document and data management platforms.
MUST HAVE: GCP QA experience
Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment.
Exceptional leadership, project management, and communication skills.
Bias for action with the ability to drive outcomes across matrixed teams and third parties.
Strong strategic thinking and adaptability in a fast-paced, global environment.

Nice To Haves

Auditor certifications and/or SQA RQAP credentials are preferred.
Prior experience in Big Pharma is preferred.

Responsibilities

Act as the primary GCP QA subject matter expert and point of contact for all GCP related matters and issues for the assigned early and late phase clinical and China clinical programs.
Ensure ongoing clinical phase and China clinical programs are in compliance with applicable health authority regulations and guidelines.
Provide quality oversight and review of key clinical and regulatory submission (e.g. IND/NDA) documents.
Own and implement the risk-based GCP audit and compliance strategy across the clinical portfolio.
Establish GCP quality governance forums and provide periodic compliance reports to senior leadership.
Lead the assessment and escalation of significant quality events, serious breaches, systemic trends, and critical and major CAPAs.
Monitor adverse trends for the assigned studies. Create and manage issue trends and make recommendations to management.
Provide strategic oversight of CROs and other critical clinical vendors.
Manage or mentor GCP QA employees, consultants, and contracted auditors.
Represent GCP QA in governance committees and major program decisions.
Work with cross-functional teams to assess and manage risks associated with vendors, supporting study compliance, data integrity, and participant safety.
Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations.
Support the creation, maintenance, and improvement of quality SOPs, manuals, templates, process maps, and approval flows to establish a robust GCP QMS.
Drive the implementation of continuous improvement initiatives across Global QA processes to enhance operational efficiency and maintain high compliance standards.
Partner with clinical functions to provide quality guidance and drive the implementation of fit-for-purpose procedures that ensure data and documentation are generated and managed in compliance with GCP.
Promote a culture of quality through effective communication, training, and proactive engagement with internal and external stakeholders.
Lead periodic reporting of key quality metrics to leadership to support continuous improvement in GCP compliance across Structure.
Develop strategies and execute/lead audits for the assigned studies, including internal processes, investigator sites, vendors/CROs, TMFs, and CSRs (both routine and for-cause).
Approve audit findings and reports, ensure effective root cause analysis and action plans and approve audit CAPAs.
Lead and oversee 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.
Lead sponsor inspection readiness and regulatory inspection activities, including inspection strategy, front-room/back-room execution, and response development.
Support global regulatory authority inspections and lead/support site and vendor inspection readiness.
Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies related to GCPs.