Associate Director, Inspection Management (GCP)

About the role

The Associate Director, Inspection Management (GCP) leads the Global Development Quality Inspection Management team in planning, executing and supporting regulatory inspections across clinical programs. Reporting to senior leadership, the role partners with Clinical Study teams, Quality Assurance and other functions to ensure inspection readiness for Regeneron‑sponsored trials worldwide.

Key responsibilities

• Notify internal and external stakeholders of upcoming GCP, GVP and GLP inspections and coordinate preparation activities.
• Develop and integrate inspection management processes, training, and mock inspections into clinical development programs.
• Provide guidance to Clinical Study Teams on inspection strategy, risk mitigation and gap analysis.
• Lead back‑room and front‑room inspection activities, track requests, and coordinate response generation.
• Prepare daily and end‑of‑inspection summaries for executive leadership and relevant stakeholders.
• Manage corrective and preventive action (CAPA) follow‑up and ensure timely closure.
• Collect, report and analyse inspection‑related quality metrics and trends.

Required profile

• Advanced knowledge of GCP, GVP and GLP regulations and their application in clinical research.
• Extensive experience supporting regulatory agency inspections of investigator sites, sponsors or CROs.
• Proven ability to work cross‑functionally and influence senior stakeholders.
• Strong analytical and problem‑solving skills with a focus on quality improvement.

Required skills

• GCP compliance
• GVP compliance
• GLP compliance
• Regulatory inspection management
• CAPA development and follow‑up
• Quality data collection and trend analysis