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; represents team professionally and credibly under pressure; maintains resilience and composure

Enterprise Leadership Skills

• Business Savviness Anticipates business and regulatory issues and shapes strategy accordingly; connects technical expertise to organizational and industry context to make strategic recommendations

• Influence Leads large teams / projects helps shape departmental strategy influences leaders peers and cross-functional partners to align on decisions and strategic direction

• Change CatalystDrives improvements (e.g. organizational and cultural changes) with broader impact; demonstrates adaptability and ability to collaborate with others to make change successful; helps others overcome resistance to change

Qualifications & experience:

• Bachelors Degree with a minimum of 10 years experience working in relevant field for associated job description (related technical role) as well as:
• People management skills
• Demonstrated deep subject matter expertise in relevant discipline PMP Change management and communication

OR

• Advanced Degree (Masters or Doctorate) with a minimum of 8 years experience working in relevant field for associated job description as well as:
• People management skills

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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