Associate Director Inspection Management (GCP)

Responsibilities

• Act as the Inspection Management Lead (IML) responsible for the effective management of GCP, GVP, and GLP inspections.
• Manage the notification of internal and external stakeholders regarding upcoming or anticipated regulatory inspections.
• Provide guidance, consultancy, and support to Clinical Study Teams in preparation for impending inspections.
• Identify opportunities for mock inspections and Investigator Site Preparation Visits in collaboration with Quality Assurance teams.
• Serve as a back room or front room lead during regulatory inspections, managing requests, inquiries, and responses.
• Manage the development of inspection responses and follow-up activities for Corrective Actions/Preventive Actions (CAPA).
• Oversee the collection, reporting, and analysis of inspection-related quality data, trends, and metrics.

Requirements

• Bachelor's degree and a minimum of 10 years of relevant healthcare or pharmaceutical industry experience.
• Extensive experience supporting Regulatory Agency Inspections of Investigator Sites, Sponsors, and CROs in a GxP environment.
• Advanced knowledge and application of GCP and/or GVP guidelines.
• Proven experience in training, supervising, mentoring, and leading a small team.
• Experience in a quality/compliance role (e.g., Quality Management, Quality Assurance) or a Clinical Development role with relevant expertise.

Preferred Qualifications

• Demonstrated ability to interface and collaborate effectively with senior management and external stakeholders.
• Strong interpersonal skills with a focus on stakeholder engagement and cross-functional collaboration.

About the Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, the company focuses on translating science into medicine to treat eye diseases, cancer, cardiovascular diseases, and rare diseases.