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 improvement initiatives that enhance efficiency, quality, scalability, compliance, and business outcomes.
• •Provide operational oversight for the validation services portfolio, ensuring effective demand management, resource allocation, workload balancing, and delivery performance across programs and platforms.
• •Lead organizational capability development and succession planning to ensure the validation organization maintains the skills, expertise, and capacity required to support current and future business needs.
• •Monitor and communicate organizational performance, risks, compliance trends, and capacity constraints to leadership, driving timely decisions and corrective actions as needed.

Strategy, Planning & Prioritization

• •Partner with BVSV and Platform Services leadership to translate strategy into priorities, roadmaps, operational plans, and measurable outcomes.
• •Establish an integrated planning process linking demand, portfolio commitments, resources, capacity, and organizational priorities.
• •Facilitate prioritization and investment discussions to ensure focus on the highest-value opportunities.
• •Monitor progress against strategic objectives and identify risks, dependencies, and areas requiring leadership action.

Operational Governance & Leadership Enablement

• •Lead the governance framework for BVSV and Platform Services, including leadership forums, decision management, escalation processes, and performance reviews.
• •Serve as a strategic partner and Chief of Staff to the leadership team.
• •Ensure decisions, commitments, and actions are tracked through execution.
• •Develop executive communications, strategic updates, and leadership materials.

Portfolio, Demand & Capacity Management

• •Provide an integrated view of service demand, delivery commitments, backlog, resource capacity, and organizational priorities.
• •Support intake, assessment, and prioritization processes across validation and platform services.
• •Identify capacity constraints, competing priorities, and resource risks and support leadership decision-making.
• •Ensure commitments remain aligned with available resources and strategic objectives.

Performance, Metrics & Business Insights

• •Establish and maintain organizational KPIs, dashboards, scorecards, and performance reporting.
• •Provide leadership visibility into service performance, demand, capacity, quality, risks, and strategic outcomes.
• •Drive measurement of business value, operational efficiency, quality improvements, and organizational performance.
• •Translate data into actionable insights and recommendations.

Operational Excellence & Continuous Improvement

• •Lead operational excellence and transformation initiatives across BVSV and Platform Services.
• •Drive simplification, standardization, automation, and process improvement opportunities.
• •Promote data-driven decision-making and adoption of AI and automation capabilities where appropriate.
• •Ensure improvements are sustainable and aligned with organizational goals.

Technical skills

• •Understanding of compliance and documentation standards (e.g., GxP, 21 CFR Part 11, and audit traceability practices)
• •Deep experience in Program and project governance and enterprise risk management
• •Advanced knowledge of automation and AI testing guard rails, including validation of ML models and automated testing pipelines
• •Strong understanding of operations of functions

Non-technical skills

• •Excellent communicator with the ability to translate technical and operational priorities into clear, actionable direction
• •Distills complex issues into decision-ready narratives; frames options, risks, and recommendations to influence senior decisions.
• •Ability to define and execute organizational strategy for validation operations across regions
• •Demonstrated success managing large, varied perspectives, and geographically distributed teams
• •Strong understanding of operational, financial, and compliance dimensions of global data delivery
• •Capable of leading transformation initiatives and fostering innovation across complex organizations
• •Leads through influence across functions/geographies; mentors global cohorts; provides structured feedback.
• •Engages vendor, data, and industry forums; repres