Director, Data Management Process, Quality & Inspection Readiness

Regeneron

. Provide strategic leadership for Data Management quality, inspection readiness, compliance, and process excellence .

Posted 10/27/2026full-timeUnited StatesLead💰 $183,100 - $305,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Clinical Data Management, focusing on quality frameworks, inspection readiness, and compliance within the biotechnology and pharmaceutical industries. Proven ability to lead teams, manage change initiatives, and establish effective governance and operational processes.

Highest-signal resume keywords

Clinical Data ManagementQuality FrameworksInspection ReadinessRegulatory CompliancePeople Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data Management QualityCAPA ManagementRoot Cause AnalysisKPI/KQI FrameworksGCP GuidelinesICH Guidelines21 CFR Part 11ALCOA+ PrinciplesProcess ImprovementOperational Metrics

Soft Skills

LeadershipMentoringStrategic ThinkingCollaborationCommunication

Tools & Technologies

Quality Management SystemsSharePoint

Industry Keywords

BiotechnologyPharmaceuticalHealth Authority InspectionsAudit SupportChange Management

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide strategic leadership for Data Management quality, inspection readiness, compliance, and process excellence
Establish and drive standardized Data Management quality approaches, process frameworks, governance, and operational execution
Serve as the primary Data Management lead for health authority inspections and audits
Lead inspection preparation, response coordination, functional representation, and inspection readiness
Develop quality frameworks covering CRO oversight, issue management, escalation pathways, and quality oversight processes
Lead quality event and CAPA management, including root cause analysis and corrective and preventive actions
Collaborate with CRO partners and internal stakeholders on quality events, remediation, and CAPA implementation
Conduct independent, risk-based reviews of study documentation and operational conduct
Establish quality review processes to identify gaps, deficiencies, training needs, and risks
Establish and leverage KPI/KQI frameworks and effectiveness checks to monitor performance, data quality, compliance, inspection readiness, training, and process performance
Lead impact assessments for new and evolving regulatory requirements
Educate and guide the Data Management organization on quality standards, regulatory expectations, and inspection readiness
Partner with Inspection Management, Quality, Process & Procedures, Learning Center of Excellence, and Change Management functions
Oversee Data Management SharePoint repositories for 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 and guidance
Lead the Data Management SME network
Represent Data Management in the Global Development Process Owner Network
Lead and contribute to cross-functional process improvement initiatives
Manage direct reports, including competency development, coaching, performance assessment, mentorship, workload prioritization, and fostering accountability and continuous improvement

Requirements

What you’ll need

Minimum Bachelor's Degree in Science, Health, Computing, or related field
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, including FDA, PMDA, MHRA, and EMA
Experience establishing and leveraging KQI/KPI frameworks, effectiveness measures, and operational metrics
Demonstrated ability to lead organizational change management initiatives
Demonstrated success solving complex business problems through strategic and critical thinking
Proven ability to lead and influence within a matrix organization
Proven ability to build collaborative relationships and influence alignment across internal and external stakeholders
Strong understanding of cross-functional activities and management of multiple and varied tasks
Excellent interpersonal, oral, and written communication skills
Demonstrated ability to effectively lead and prioritize within a fast-paced, evolving, highly regulated environment
Ability to work 4 days per week on site
Ability to travel; 25% travel may be required

Benefits

Comp & perks

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 benefits
Paid time off
Family support benefits
Reasonable accommodation during the recruitment process for applicants with known disabilities or chronic illnesses, where required