Senior Director, GCP Quality Assurance

About the role

The Senior Director, GCP Quality Assurance provides strategic leadership and operational oversight for Good Clinical Practice (GCP) Quality Assurance activities supporting the company’s clinical development programs. This role is accountable for ensuring that clinical trials are conducted, documented, and reported in compliance with applicable regulatory requirements, company policies, and global GCP standards while maintaining a continuous state of inspection readiness. The Senior Director serves as a senior QA leader and strategic partner to Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, Biostatistics, and external service providers. The role is accountable for GCP quality systems, clinical quality risk management, CRO and vendor oversight, audit strategy, inspection readiness, quality metrics, and the maturation of fit-for-purpose GCP processes that embed quality by design across the clinical lifecycle.

Responsibilities

• Define, implement, and continuously mature the GCP QA strategy aligned with clinical development objectives, corporate priorities, and global regulatory expectations.
• Serve as the senior GCP QA partner to Clinical Operations and cross-functional stakeholders, providing strategic guidance on GCP compliance, clinical quality risk management, and inspection readiness.
• Champion a proactive culture of quality, compliance, patient safety, data integrity, and continuous improvement across clinical programs.
• Build, lead, mentor, and develop GCP QA capability and/or external QA resources as the function scales.
• Ensure GCP processes are phase-appropriate, risk-based, compliant, scalable, and suitable for outsourced or hybrid clinical development models.
• Lead or provide senior QA oversight for the development, review, approval, implementation, and lifecycle management of GCP-related SOPs, policies, work instructions, and training materials.
• Provide senior QA oversight for GCP activities conducted internally and by CROs, investigator sites, vendors, and other service providers.
• Serve as sponsor QA counterpart to CRO QA groups and other external partner quality functions, ensuring clear standards, escalation pathways, and issue resolution.
• Lead GCP vendor qualification, risk-based audit strategy, issue escalation, performance oversight, and ongoing vendor governance using risk-based principles.
• Review, approve, and maintain QA oversight of GCP-related quality agreements, vendor oversight plans, audit plans, and CAPA commitments.
• Provide senior QA review of key clinical and regulatory documents, as appropriate, to support clinical development quality and submission readiness.
• Own the risk-based GCP audit program, including CRO audits, investigator site audits, vendor audits, TMF/eTMF audits, and system or process audits as applicable.