Senior Director, Quality Assurance GCP

• Lead and oversee the development, planning, and execution of audits of Contract Research Organizations (CROs), clinical sites, and other service providers, ensuring compliance with Food and Drug Administration, World Health Organization, ICH‑GCP, and other applicable regulatory requirements, as well as company policies and procedures.
• Own and lead GCP regulatory inspection readiness, inspection conduct, response development, and follow‑up for FDA and other health authority inspections.
• Collaborate with Clinical Development Operations and cross‑functional stakeholders to ensure clinical studies are conducted in compliance with all applicable regulatory standards and to maintain a state of continuous inspection readiness.
• Oversee and manage the clinical quality database, including audit observations and inspection findings (e.g., 483s), to support quality trend analysis, risk assessment, and proactive compliance management.
• Organize and oversee pre‑ and post‑study document reviews and direct corrective and preventive action (CAPA) planning, implementation, and effectiveness verification.
• Manage quality events, deviations, and investigations.
• Provide senior‑level input and review of technical and clinical documents in support of clinical development programs and regulatory submissions.
• Provide leadership in the continuous improvement of GCP processes, systems, and practices across the organization.
• Monitor, review, and communicate audit and inspection outcomes, quality trends, and compliance risks to clinical and senior management.
• Oversee and conduct internal audits of the Trial Master File (TMF) to ensure GCP compliance and inspection readiness.
• Lead, develop, and evaluate the QA GCP team, including hiring, performance management, coaching, and succession planning to ensure effective operation and scalability of the function.
• Collaborate with a cross‑functional and interactive team to embed quality throughout the clinical lifecycle.
• Ability to travel to clinical sites, CROs, and vendors to support audits and inspections as needed (10–20% of time).

Qualifications:

• Bachelor’s degree in Science (required), preferably in Pharmaceutical Sciences, Technology, Life Sciences, or a related field; advanced degree preferred.
• 15+ years of relevant experience in a pharmaceutical or biotech clinical quality assurance environment, with deep expertise in GCP.
• Proven experience leading and developing QA teams and providing functional oversight in a growing organization.
• Demonstrated experience leading GCP audits and owning regulatory inspections, including direct interaction with FDA and/or global health authorities.
• Experience overseeing quality activities supporting early‑ and late‑stage clinical development programs
• Demonstrated knowledge of applicable regulations and ICH GCP guidelines.

Salary Range:

$235,000 - 275,000 USD