Director, Data Management Process, Quality & Inspection Readiness

Director, Data Management Process, Quality, and Inspection Readiness

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.

Work Location:

Warren, NJ, Tarrytown, NY or Armonk, NY Hybrid; 4 days per week on site 25% Travel may be required.

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 time points 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.

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…