Director, Data Management Process, Quality & Inspection Readiness

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 check 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.