About this role
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:
• Bachelor's Degree with a minimum of 10 year's 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 year's experience working in relevant field for associated job description, as well as: • People management skills
clinicaltrialjobs EligibleforERP #GDMS
Required Skills: Adaptability, Business Agility, Business Decisions, Business Process Improvements, Change Management, Clinical Data Management, Decision Making, Enterprise Leadership, Good Clinical Practice (GCP), Organizational Leadership, Planning, Situational Leadership, Stakeholder Management, Strategic Leadership, Strategic Planning, Strategy Deployment Preferred Skills:
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The salary range for this role is $173,200.00 - $272,600.00 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 employee’s 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 https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): No Job Posting End Date: 10/2/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.