Director, Data Management Process, Quality & Inspection Readiness

Relha LLC; Northern (KY); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Relha LLC seeks a Director of Data Management Process, Quality & Inspection Readiness to lead quality, governance, and inspection readiness across Data Management. You will ensure GCP/ICH compliance, oversee CAPA, issue management, and audits, and partner with CROs and stakeholders.

This role requires 12+ years in Clinical Data Management, 5+ years of leadership, and a proven track record driving process improvements in a global development setting.

Qualifications

• Minimum Bachelor’s Degree (Science, Health, Computing, or related field).
• 12+ years in Clinical Data Management within biotech/pharma.
• 5+ years of people management and leadership experience.
• Expert knowledge of GCP, ICH guidelines, 21 CFR Part 11, ALCOA+ and inspection readiness.

Responsibilities

• Lead Data Management quality, inspection readiness, and process governance across the organization.
• Develop quality frameworks, CAPA, issue management, escalation pathways and quality oversight.
• Coordinate health authority inspections, prep, response, and CRO collaboration.
• Establish KPI/KQI frameworks for visibility on data quality and compliance.
• Educate and guide the organization on regulatory expectations and inspection readiness.

Skills

Data management

Quality management

Inspection readiness

CAPA

Regulatory compliance

Cross-functional leadership

GCP/ICH knowledge

Education

Bachelor's degree in Science/Health/Computing

Tools

SharePoint

Quality management systems

Job description

Director, Data Management Process, Quality & Inspection Readiness

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

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.

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 experience. In 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

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.