Director, Data Management Process, Quality & Inspection Readiness

Initial Therapeutics, Inc.; New Jersey; Hybrid; USD 183,100 - 305,200; Full time

Job summary

Initial Therapeutics, Inc. is seeking a Director for Data Management Process, Quality, and Inspection Readiness. This role involves strategic leadership for data management quality and regulatory compliance, ensuring standardized operational excellence while preparing for health authority inspections.

With a focus on developing governance and continuous improvement frameworks, the ideal candidate should possess deep expertise in clinical data management and a proven ability to lead teams towards inspection-ready execution. This hybrid position requires some travel and offers a competitive salary range.

Qualifications

• Minimum of 12 years in Clinical Data Management.
• 5+ years of people management experience.
• Expert knowledge of clinical data management principles.

Responsibilities

• Develop Data Management quality frameworks.
• Lead quality event and CAPA management activities.
• Collaborate with CRO partners on quality events.

Skills

Data Management Quality

Leadership

Regulatory Compliance

Process Improvement

CAPA Management

Education

Bachelor's Degree in Science, Health, Computing or related field

Tools

Data Management Systems

Job description

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 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

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.