Associate Director Inspection Management (GCP)
On-site · Dublin, Leinster, Ireland
Job Summary
Associate Director Inspection Management leads inspection readiness and responses for GCP, GVP, and GLP inspections across Regeneron-sponsored clinical trials; builds partnerships with Clinical Study Teams and GDQA to integrate inspection management processes, provide guidance pre-inspection, coordinate mock inspections and Investigator Site Preparation Visits, manage inspection updates and CAPA activities, and report insights to GD Executive and Senior Management; requires advanced knowledge of GCP/GVP, extensive experience with regulatory inspections in a GxP environment, and proven leadership in training and mentoring staff.
Required Qualifications
- Bachelor's degree in healthcare/pharmaceutical field
- minimum 10 years of healthcare/pharmaceutical industry experience
- experience in quality/compliance roles (Quality Management/Quality Assurance) or Clinical Development with GCP/GVP expertise
- experience in training, supervising, and mentoring staff
- experience supporting Regulatory Agency Inspections of Investigator Sites, Sponsors and CROs in a GxP environment
- strong interpersonal skills and stakeholder engagement
- ability to provide guidance and training on quality/compliance topics
- ability to manage inspection preparation, mock inspections, and CAPA follow-up
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