Director, Data Management Process, Quality & Inspection Readiness
Regeneron
August 23, 2026
Remote friendly (Warren, NJ)
United States
Operations
Role Responsibilities
- Provide strategic leadership for Data Management quality and compliance, resolving complex and systemic issues.
- Develop Data Management quality frameworks (CRO oversight, issue management, escalation pathways, quality oversight) aligned with GCP, ICH, global regulatory requirements, and company quality standards.
- Lead quality events and CAPA management (root cause analysis; sustainable corrective/preventive actions) to strengthen controls and inspection readiness.
- Collaborate with CRO partners and internal stakeholders on quality events, escalation, remediation, and CAPA implementation.
- Lead Data Management inspection readiness and audit support, directing preparation, coordination, and response for health authority inspections.
- Conduct independent, risk-based reviews of study documentation and operational conduct to identify gaps and ensure sustained inspection readiness.
- Establish Data Management quality review processes; document risks and training needs; remediate early.
- Define and leverage KPI/KQI frameworks and effectiveness checks to drive continuous improvement.
- Lead impact assessments for new regulatory requirements and educate/guidance the organization.
- Maintain partnerships with Inspection Management/Quality stakeholders and oversee SharePoint repositories for quality/inspection documentation.
- Own and drive Data Management process governance and continuous improvement; lead implementation/change management; maintain role-based training frameworks; lead the SME network; support cross-functional process improvement.
- Manage direct reports (performance, coaching, competency development) and foster a culture of accountability and quality.
Qualifications/Required Skills
- BS (Science/Health/Computing or related) + 12+ years Clinical Data Management in biotech/pharma/health.
- 5+ years people management, leadership, and mentoring.
- Expert knowledge of clinical data management, quality frameworks, and inspection readiness in global clinical development.
- Deep knowledge of GCP, ICH, 21 CFR Part 11, and ALCOA+ principles.
- Experience leading Data Management quality/compliance/inspection readiness, CAPA, issue escalation, and process governance.
- Experience supporting multiple health authority inspections (e.g., FDA/PMDA/MHRA/EMA) including preparation, response, remediation, and functional representation.
- Experience with KQI/KPI and effectiveness measures.
- Ability to lead change management; solve complex problems; influence in a matrix organization.
- Excellent communication skills and ability to prioritize in a fast-paced, highly regulated environment.
Application Instructions
- Apply now.
- Provide strategic leadership for Data Management quality and compliance, resolving complex and systemic issues.
- Develop Data Management quality frameworks (CRO oversight, issue management, escalation pathways, quality oversight) aligned with GCP, ICH, global regulatory requirements, and company quality standards.
- Lead quality events and CAPA management (root cause analysis; sustainable corrective/preventive actions) to strengthen controls and inspection readiness.
- Collaborate with CRO partners and internal stakeholders on quality events, escalation, remediation, and CAPA implementation.
- Lead Data Management inspection readiness and audit support, directing preparation, coordination, and response for health authority inspections.
- Conduct independent, risk-based reviews of study documentation and operational conduct to identify gaps and ensure sustained inspection readiness.
- Establish Data Management quality review processes; document risks and training needs; remediate early.
- Define and leverage KPI/KQI frameworks and effectiveness checks to drive continuous improvement.
- Lead impact assessments for new regulatory requirements and educate/guidance the organization.
- Maintain partnerships with Inspection Management/Quality stakeholders and oversee SharePoint repositories for quality/inspection documentation.
- Own and drive Data Management process governance and continuous improvement; lead implementation/change management; maintain role-based training frameworks; lead the SME network; support cross-functional process improvement.
- Manage direct reports (performance, coaching, competency development) and foster a culture of accountability and quality.
Qualifications/Required Skills
- BS (Science/Health/Computing or related) + 12+ years Clinical Data Management in biotech/pharma/health.
- 5+ years people management, leadership, and mentoring.
- Expert knowledge of clinical data management, quality frameworks, and inspection readiness in global clinical development.
- Deep knowledge of GCP, ICH, 21 CFR Part 11, and ALCOA+ principles.
- Experience leading Data Management quality/compliance/inspection readiness, CAPA, issue escalation, and process governance.
- Experience supporting multiple health authority inspections (e.g., FDA/PMDA/MHRA/EMA) including preparation, response, remediation, and functional representation.
- Experience with KQI/KPI and effectiveness measures.
- Ability to lead change management; solve complex problems; influence in a matrix organization.
- Excellent communication skills and ability to prioritize in a fast-paced, highly regulated environment.
Application Instructions
- Apply now.