Director, Clinical Data Management, Strategy and Operations Lead - Hybrid

** Job Description*
* ** Validation Strategy, Governance & Compliance*
* + Define and lead enterprise Business System Validation strategy across domains and platforms, ensuring alignment with SDLC principles, data integrity requirements, regulatory expectations, and Quality Management Systems (QMS).

+ Oversee validation risk management and governance, ensuring consistent application of risk-based validation approaches that balance compliance, quality, and business value.

+ Partner with leadership to define and evolve enterprise validation capabilities, operating models, standards, and future-state strategies.

+ Establish governance mechanisms to monitor validation readiness, cycle times, compliance posture, risks, capacity, and operational performance across platforms and programs, escalating gaps to senior leadership as appropriate.

+ Lead strategic alignment of validation practices with platform roadmaps, digital transformation initiatives, automation programs, and technology delivery plans.

** Quality Oversight & Continuous Improvement*
* + Provide oversight of validation execution quality, testing effectiveness, defect trends, and remediation activities across validation programs.

+ Proactively identify systemic validation gaps, compliance risks, and process deficiencies, driving corrective and preventive actions (CAPAs) to strengthen quality, inspection readiness, and operational effectiveness.

+ Drive continuous improvement initiatives that improve validation efficiency, standardization, scalability, and compliance outcomes.

+ Lead operating model enhancements based on audit findings, regulatory expectations, inspection observations, lessons learned, and performance metrics.

** Documentation, Inspection Readiness & Operational Excellence*
* + Govern validation frameworks, policies, methodologies, standards, and lifecycle documentation to ensure consistent application and regulatory compliance across systems, platforms, automation solutions, databases, and digital capabilities.

+ Establish and manage enterprise validation KPIs, scorecards, quality metrics, and governance dashboards to monitor compliance and organizational performance.

+ Provide operational leadership, mentoring, and capability development across validation teams to ensure consistent execution and technical excellence.

+ Ensure alignment of validation activities with enterprise security, privacy, data protection, records management, and QMS requirements.

+ Lead preparation for internal audits, supplier assessments, and regulatory inspections by ensuring validation documentation, evidence, and processes remain inspection-ready.

+ Oversee audit responses, inspection observations, CAPA commitments, and remediation activities to ensure timely and sustainable resolution.

+ Represent Business Validation Services in enterprise governance, quality, compliance, and Center of Excellence forums to drive harmonization of standards, templates, methodologies, and best practices across the organization

** Additional responsibilities*
* + Partner with BVSV and Platform Services leadership to align validation strategy, portfolio priorities, resource capacity, organizational objectives, and delivery commitments, ensuring effective execution across the validation organization and supported platforms.

+ Establish and monitor enterprise validation KPIs, dashboards, scorecards, and governance forums to provide visibility into validation readiness, compliance posture, inspection readiness, operational performance, risks, resource utilization, and capacity planning.

+ Drive operational excellence across the Business Validation Services organization through standardization, automation, AI-enabled validation capabilities, workforce planning, and continuous…