Global Head of Data Management Quality & Inspection Readiness

BioSpace; New Jersey; On-site; USD 183,000 - 305,000; Full time

Job summary

Regeneron is seeking a Director of Data Management Quality, Inspection Readiness, and Process Excellence to lead standardized quality systems across Data Management. You will guide CRO oversight, CAPA, and regulatory inspection responses, ensuring readiness for FDA and other authorities.

The role demands strategic leadership, robust governance, global regulatory awareness, and the ability to drive continuous improvement in a highly regulated environment.

Qualifications

• Bachelor's degree in Science, Health, Computing, or related field.
• 12+ years in Clinical Data Management within biotech/pharma.
• Experience leading quality, inspection readiness, and process governance.

Responsibilities

• Provide strategic leadership for data management quality and inspection readiness.
• Develop quality frameworks and governance to support compliance and operational excellence.
• Lead CAPA processes, risk-based reviews, and regulatory inspections representation.

Skills

Quality governance

Inspection readiness

Regulatory compliance

CAPA management

Cross-functional leadership

Education

Bachelor's degree

Job description

Regeneron is seeking a Director of Data Management Quality, Inspection Readiness, and Process Excellence to lead standardized quality systems across Data Management. You will guide CRO oversight, CAPA, and regulatory inspection responses, ensuring readiness for FDA and other authorities.

The role demands strategic leadership, robust governance, global regulatory awareness, and the ability to drive continuous improvement in a highly regulated environment.