Director, Data Management Process, Quality & Inspection Readiness

Regeneron Pharmaceuticals • Warren, MI

11d • Onsite

About The Position

The Director, Data Management Process, Quality, and Inspection Readiness provides strategic leadership for Data Management quality, inspection readiness, and process excellence. The role establishes and drives standardized approaches to quality, process frameworks, governance, compliance, and operational execution, ensuring alignment with global regulatory requirements, GCP, and industry best practices. The Director serves as the primary Data Management lead for health authority inspections and audits, coordinating preparation and responses, representing the function, and ensuring teams are ready for regulatory inspections. The role also owns development, governance, and continuous improvement of Data Management processes, training programs, and operational frameworks to support standardized, scalable, compliant, and inspection-ready execution.

The position is based at one of the listed New Jersey or New York locations and requires on-site work four days per week. Travel may be required up to 25%.

The Director leads Data Management quality and compliance frameworks, quality event and CAPA activities, inspection readiness and audit support, risk-based reviews, and quality performance measurement. The role guides the organization on regulatory expectations and quality practices, maintains centralized repositories for quality, inspection readiness, process, and training documentation, and partners with internal teams and CROs. It also leads process and training governance, implementation and change management, and the Data Management SME network. As a people manager, the Director supports direct reports’ development and performance, provides mentorship, and fosters accountability, collaboration, continuous improvement, and quality.

Regeneron describes its total rewards package as potentially including annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits. Availability may depend on country and role.

Requirements

• Bachelor’s degree in Science, Health, Computing, or a related field.
• 12+ years of Clinical Data Management experience within the biotechnology, pharmaceutical, or health-related industry.
• 5+ years of people management, leadership, and mentoring experience.
• Expert knowledge of clinical data management principles, processes, quality frameworks, and inspection readiness practices in a global clinical development environment.
• Deep understanding of global regulatory requirements and standards, including GCP, ICH guidelines, 21 CFR Part 11, ALCOA+ principles, and inspection readiness expectations.
• Demonstrated experience leading Data Management quality, compliance, inspection readiness, audit support, and process governance activities.
• Experience developing, implementing, and continuously improving departmental processes, quality standards and frameworks, and operational controls.
• Strong knowledge of quality management systems, CAPA processes, issue management, escalation frameworks, and continuous improvement methodologies.
• Experience supporting multiple health authority inspections across different authorities, including preparation, response coordination, remediation, and functional representation.
• Experience establishing and using KQI/KPI frameworks, effectiveness measures, and operational metrics for quality oversight, compliance monitoring, and process improvement.
• Demonstrated ability to lead organizational change management initiatives involving new processes, quality standards, and operational frameworks.
• Demonstrated success solving complex business problems through strategic and critical thinking.
• Ability to lead and influence in a matrix organization, driving alignment and outcomes with cross-functional stakeholders without direct authority.
• Ability to build collaborative relationships and influence alignment across internal and external stakeholders.
• Strong understanding of cross-functional activities and ability to manage multiple varied tasks with enthusiasm and attention to detail.
• Excellent interpersonal, oral, and written communication skills.
• Ability to lead and prioritize in a fast-paced, evolving, highly regulated environment.
• Ability to work on site four days per week at a listed location; travel may be required up to 25%.

Responsibilities

• Provide strategic leadership for Data Management quality, compliance, inspection readiness, and process excellence.
• Develop and oversee quality frameworks, including CRO oversight, issue management, escalation pathways, and quality oversight processes.
• Ensure quality frameworks and operational activities align with GCP, ICH guidelines, global regulatory requirements, and company standards.
• Lead quality event and CAPA management, including root cause analysis and sustainable corrective and preventive actions.
• Collaborate with CRO partners and internal stakeholders on quality events, escalations, remediation, and CAPA implementation.
• Lead Data Management inspection readiness and audit support, including preparation, coordination, and responses to health authority inspections.
• Conduct independent, risk-based reviews of study documentation and operational conduct to identify gaps and support sustained inspection readiness.
• Establish quality review processes to identify process gaps, deficiencies, training needs, and risks for early remediation.
• Establish and use KPI and KQI frameworks to monitor performance, data quality, and compliance trends and support proactive decisions and improvement.
• Define and monitor effectiveness measures for quality, compliance, inspection readiness, training, and process performance.
• Lead impact assessments for new and evolving regulatory requirements and update processes, standards, and practices as appropriate.
• Educate and guide Data Management teams on quality standards, regulatory expectations, and inspection readiness.
• Partner with Inspection Management and Quality stakeholders on readiness activities, standards, expectations, and remediation strategies.
• Oversee Data Management SharePoint repositories for centralized access to current quality, inspection readiness, process, and training documentation.
• Own and drive development, governance, and continuous improvement of Data Management processes.
• Develop and execute implementation and change management plans for new and revised processes.
• Establish and maintain role-based training frameworks, including development, maintenance, and delivery of training and guidance.
• Lead the Data Management SME network to provide subject matter expertise, process ownership, and functional support coverage.
• Represent Data Management in the Global Development Process Owner Network.
• Partner with Process & Procedures, Learning Center of Excellence, and Change Management functions to align processes and training.
• Lead and contribute to cross-functional process improvement initiatives as needed.
• Manage direct reports’ performance and development, including competency development, coaching, and annual performance assessment.
• Provide leadership, mentorship, and guidance to direct reports and foster accountability, collaboration, continuous improvement, and quality.
• Support prioritization and workload management to ensure effective utilization.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits may include medical, dental, vision, life, and disability coverage, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Director