Head of Data Management Quality & Inspection Readiness

Regeneron Pharmaceuticals, Inc; Cambourne; On-site; GBP 112,000 - 142,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Director of Data Management Quality and Inspection Readiness to lead strategy and execution for Data Management quality, inspection readiness, and process excellence.

The role drives standardized approaches, governance, and regulatory compliance across global health authority inspections. The position requires building robust quality frameworks, CAPA, risk-based reviews, and ongoing training programs to ensure scalable, compliant, and inspection-ready

Qualifications

• 12+ years in Clinical Data Management within biotech/pharma.
• 5+ years of people management and leadership.
• Expert knowledge of clinical data management, quality frameworks, and inspection readiness.
• Strong understanding of global regulatory requirements (GCP, ICH, 21 CFR 11).
• Experience leading data management quality, compliance, and audit support.

Responsibilities

• Provide strategic leadership for Data Management quality and compliance.
• Develop data management quality frameworks, including oversight, issue management, and CAPA processes.
• Ensure alignment with GCP, ICH, global regulations and company quality standards.
• Lead data management inspection readiness and health authority inspection support.
• Oversee KPI/KQI frameworks to drive quality oversight and continuous improvement.
• Educate and guide the organization on quality standards and inspection readiness.

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Director of Data Management Quality and Inspection Readiness to lead strategy and execution for Data Management quality, inspection readiness, and process excellence.

The role drives standardized approaches, governance, and regulatory compliance across global health authority inspections. The position requires building robust quality frameworks, CAPA, risk-based reviews, and ongoing training programs to ensure scalable, compliant, and inspection-ready