Director, Data Management Process, Quality & Inspection Readiness

About the role

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.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Define, monitor, and perform effectiveness checks measures for Data