Director, Data Management Process, Quality & Inspection Readiness

Build our future together:

The Director Data Management Process Quality and Inspection Readiness provides strategic leadership for Data Management quality inspection readiness and process excellence. This role is accountable for establishing and driving standardized approaches to Data Management quality process frameworks governance compliance and operational execution while ensuring compliance with global regulatory requirements GCP and industry best practices. The position serves as the primary Data Management lead for health authority inspections and audits accountable for inspection preparation response coordination functional representation and ensuring teams are prepared to effectively represent the function during regulatory addition the role also owns and drives the development governance and continuous improvement of Data Management processes training programs and operational frameworks to support standardized scalable compliant and inspection-ready execution across the Data Management organization.

When & where:

• Work Location: Warren NJ Tarrytown NY or Armonk NY

• 4 days per week on site

• 25% Travel may be required

Discover your role:

Data Management Quality and Inspection Readiness

• Provide strategic leadership for Data Management quality and compliance ensuring consistent application of quality standards and resolution of complex and systemic issues.

• Develop Data Management quality frameworks including CRO oversight issue management escalation pathways and quality oversight processes to support proactive identification and management of operational quality issues and compliance gaps.

• Ensure Data Management quality frameworks and operational activities are aligned with GCP ICH guidelines global regulatory requirements and company quality standards.

• Lead quality event and CAPA management activities including root cause analysis and implementation of sustainable corrective and preventive actions. Leverage insights to strengthen controls improve processes and enhance inspection readiness.

• Collaborate with CRO partners and internal stakeholders on quality events issue escalation remediation activities and CAPA implementation.

• Lead Data Management inspection readiness and audit support; direct preparation coordination and response for health authority inspections.

• Lead and conduct independent risk-based reviews of study documentation and operational conduct at defined and ad hoc timepoints to identify gaps strengthen compliance and ensure sustained inspection readiness.

• Establish Data Management quality review processes to identify process gaps and deficiencies training needs and the documentation of risks enabling early remediation.

• Establish and leverage Data Management KPI & KQI frameworks to provide visibility into performance data quality & compliance trends driving proactive decision-making continuous improvement & innovation across the portfolio.

• Define monitor and perform effectiveness checks measures for Data Management quality compliance inspection readiness training and process performance to drive continuous improvement and operational excellence.

• Lead impact assessments for new and evolving regulatory requirements ensuring appropriate updates to Data Management processes quality standards and operational practices.

• Educate and guide the Data Management organization on quality standards regulatory expectations and inspection readiness practices.

• Establish and maintain strong partnerships with Inspection Management and Quality stakeholders to ensure alignment on inspection readiness activities quality standards compliance expectations and remediation strategies.

• Oversee Data Management SharePoint repositories to support centralized access to current quality and inspection readiness documentation.

Data Management Process and Training

• Own and drive the development governance and continuous improvement of Data Management processes to support scalable standardized compliant and inspection-ready execution.

• Develop and execute robust implementation and change management plans for new and revised Data Management processes to ensure consistent adoption operational effectiveness and sustainable execution.

• Establish & maintain training frameworks to support consistent implementation through development maintenance and delivery of role-based training and guidance.

• Lead the Data Management SME network to ensure designated subject matter expertise process ownership and functional support coverage across Data Management.

• Oversee Data Management SharePoint repositories to support centralized access to current process and training documentation.

• Serve as a Data Management representative in the Global Development Process Owner Network.

• Establish and maintain strong partnerships with the Process & Procedures Learning Center of Excellence Change Management functions to ensure alignment on Data Management processes and training.

• Lead and contribute to cross-functional process improvement initiatives as required.

People Management

• Responsible for line management and performance of direct reports including the development of competencies coaching and assessment of annual performance.

• Provide leadership mentorship and guidance to direct reports fostering skill development knowledge sharing and operational excellence.

• Foster a culture of accountability collaboration continuous improvement and quality.

• Support prioritization and workload management to ensure effective utilization.

This role requires:

• Minimum Bachelors Degree (Science Health Computing or related field) with 12 years in Clinical Data Management within the biotechnology pharmaceutical or health related industry.

• 5 years of people management leadership and mentoring

• Expert knowledge of clinical data management principles processes quality frameworks and inspection readiness practices within a global clinical development environment.

• Deep understanding of global regulatory requirements and industry 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.

• Demonstrated 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.

• Demonstrated experience supporting multiple health authority inspections across different health authorities (e.g. FDA PMDA MHRA EMA etc..) including inspection preparation response coordination remediation activities and functional representation during regulatory inspections.

• Experience establishing and leveraging KQI / KPI frameworks effectiveness measures and operational metrics to drive quality oversight compliance monitoring and process improvement.

• Demonstrated ability to lead organizational change management initiatives including implementation of new processes quality standards and operational frameworks.

• Demonstrated success in solving complex business problems through strategic and critical thinking.

• Proven ability to lead and influence within a matrix organization driving alignment and outcomes with cross-functional stakeholders without direct authority

• Proven ability to build strong collaborative relationships and influence alignment across key internal and external stakeholders.

• Strong understanding of cross-functional activities and management of multiple and varied tasks with enthusiasm and attention to detail.

• Excellent interpersonal oral and written communication skills.

• Demonstrated ability to effectively lead and prioritize within a fast-paced evolving and highly regulated environment.

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion or belief (or lack thereof) sex sexual orientation gender identity or expression gender reassignment marital or civil partnership status civil status pregnancy or parental status age disability nationality citizenship status ethnic or national origin membership of the Traveler community familial status genetic information military or veteran status or any other characteristic protected under applicable law. Where required we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process unless such accommodation would impose undue hardship.

Where necessary we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment specific role level and your skills and some countries collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include depending on country and role: annual bonuses or other incentive plans equity awards pension or retirement benefits 401(k) company match health and wellness programs fitness centers insurance benefits (e.g. medical dental vision life and disability) paid time off and family support benefits. For additional information about Regeneron benefits in the U.S. please visit For other locations additional information will be provided during the recruitment process. If you have any questions please speak with your recruiter.

Please be advised that at Regeneron we believe we do our best work when we are together. For that reason many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)