Regeneron Pharmaceuticals, Inc

Director, Data Management Process, Quality & Inspection Readiness

Regeneron Pharmaceuticals, Inc • $183K — $305K *
Warren, MI 48089In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Science, Health, Computing, or related field
  • 12+ years of experience in Clinical Data Management within biotechnology or pharmaceuticals
  • 5+ years of experience in people management and leadership
  • Expert knowledge of clinical data management principles and inspection readiness practices
  • Strong understanding of global regulatory requirements, including GCP and ICH guidelines
  • Demonstrated experience in leading quality, compliance, and inspection readiness activities
  • Ability to manage cross-functional collaborative efforts and relationships.

Responsibilities

  • Provide strategic leadership for Data Management quality and compliance.
  • Develop comprehensive Data Management quality frameworks and oversight processes.
  • Ensure alignment of operational activities with regulatory standards and company policies.
  • Lead and manage quality event and CAPA activities, focusing on continuous improvement.
  • Oversee preparation and coordination for health authority inspections and audits.
  • Establish and analyze Data Management KPIs and KQIs to monitor performance.
  • Educate and guide teams on quality standards and inspection readiness practices.

Benefits

  • Hybrid work model with four days on-site per week
  • Potential for 25% travel
  • Access to centralized quality and training documentation
  • Opportunities for leadership and mentorship development
  • Cross-functional collaboration initiatives
Full Job Description
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 inspections. In 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
  • Hybrid; 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 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.


Salary Range (annually)
$183,100.00 - $305,200.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ
REGN
* Ladders Estimates

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