Director, Data Management Process, Quality & Inspection Readiness

Regeneron

Director of Data Management at Regeneron overseeing quality, inspection readiness, and process excellence. Establishing frameworks and leading inspections in the biotechnology field.

Posted 6/19/2026full-timeWarren • New Jersey, New York • 🇺🇸 United StatesLead💰 $183,100 - $305,200 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

The Director, Data Management Process, Quality, and Inspection Readiness provides strategic leadership for Data Management quality, inspection readiness, and process excellence.
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.
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 inspections.
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.

Requirements

What you’ll need

Minimum Bachelor's 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.

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
Insurance benefits (e.g. medical, dental, vision, life and disability)
Paid time off
Family support benefits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical data managementquality frameworksinspection readinessregulatory complianceGCPICH guidelines21 CFR Part 11ALCOA+ principlesKQI frameworksKPI frameworks

Soft Skills

leadershipmentoringstrategic thinkingcritical thinkingorganizational change managementcollaborationinfluencecommunicationproblem-solvingattention to detail