Global Data Management Quality & Inspection Lead

Regeneron Pharmaceuticals; United States; Hybrid; USD 183,000 - 305,000; Full time

Job summary

Regeneron Pharmaceuticals seeks a Director of Data Management Quality and Inspection Readiness to provide strategic leadership for quality, governance, and compliance across global programs.

You will own inspection readiness, CAPA processes, and KPI frameworks, ensuring alignment with GCP and ICH guidelines while coordinating with CROs and internal stakeholders. Hybrid work with on-site collaboration is required.

Qualifications

• Bachelor’s degree with 12+ years in Clinical Data Management within biotech/pharma.
• Strong leadership, global regulatory knowledge, and inspection readiness.
• Experience developing quality frameworks and CAPA programs.

Responsibilities

• Lead Data Management quality, compliance, and inspection readiness across programs.
• Develop standardized quality frameworks, governance, and training.
• Coordinate health authority inspections and CRO partnerships.
• Drive continuous improvement in data management processes and KPIs.
• Mentor teams and manage cross-functional process improvements.

Skills

Leadership

Regulatory knowledge

Data Management quality

Inspection readiness

CAPA management

Stakeholder collaboration

Change management

Education

Bachelor's degree in Science/Health/Computing

12+ years in Clinical Data Management

Tools

SharePoint

Job description

Regeneron Pharmaceuticals seeks a Director of Data Management Quality and Inspection Readiness to provide strategic leadership for quality, governance, and compliance across global programs.

You will own inspection readiness, CAPA processes, and KPI frameworks, ensuring alignment with GCP and ICH guidelines while coordinating with CROs and internal stakeholders. Hybrid work with on-site collaboration is required.