Director, Business System Validation

MSD

Director of Business System Validation overseeing validation strategies and team performance at a major healthcare company. Ensuring process optimization and regulatory compliance for quality management across systems and platforms.

Posted 7/23/2026full-timeRahway • New Jersey • 🇺🇸 United StatesLead💰 $173,200 - $272,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in System Validation, Quality Assurance, and Testing Leadership, with a strong focus on compliance, risk management, and operational governance. Proven ability to lead teams, optimize processes, and ensure alignment with enterprise quality management systems.

Highest-signal resume keywords

System Validation ExpertiseQuality Assurance LeadershipPeople Management ExperienceRegulatory Compliance ManagementOperational Governance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Validation Strategy DevelopmentRisk ManagementPerformance ManagementProcess OptimizationData IntegrityAudit PreparednessKPI ManagementGovernance FrameworksTechnical CapabilitiesValidation Documentation

Soft Skills

Strategic LeadershipCoaching and MentoringTeam AlignmentCommunicationEmployee Relations Management

Tools & Technologies

Enterprise Quality Management SystemsAutomation ToolsGovernance DashboardsValidation Frameworks

Industry Keywords

SDLC PrinciplesCompliance RisksValidation ReadinessAudit ResponsesInspection-Ready Requirements

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

Provide strategic leadership and direction to validation teams within an assigned geography
Oversee performance management, organizational capability building and process optimization
Partner with other leaders on workforce strategy, talent development, and alignment on enterprise Business Validation goals
Define and lead validation strategy across domains and platforms, ensuring alignment with our company SDLC principles, data integrity, and enterprise quality management systems (QMS)
Oversee validation risk management, ensuring balanced, risk-based approaches to coverage and compliance
Work with leadership to set strategy for business system validation capabilities to be built
Establish operational governance mechanisms to monitor validation readiness, cycle times, risks, and compliance across platforms and programs, escalating gaps to senior leadership as appropriate
Proactively identify systemic validation gaps, assess compliance risks, and drive corrective and preventive actions to improve validation quality, audit preparedness, and operational performance
Govern validation frameworks, policies, and methodologies to ensure consistent application and regulatory compliance across databases, automation tools, and study/standards and system platforms
Establish and manage enterprise-level validation KPIs (Key Performance Indicators), scorecards, and governance dashboards
Provide operational leadership and mentoring across validation teams, ensuring consistent execution of validation processes and technical capabilities
Ensure alignment of validation activities with our Company's enterprise security, data protection, privacy, and QMS policies, partnering with relevant teams to ensure full policy adherence
Provide leadership during internal audits and external regulatory inspections by preparing evidence, responding to inquiries, and ensuring that validation documentation meets inspection-ready requirements
Ensure inspection readiness by overseeing validation documentation, audit responses, and evidence availability
Represent validation in enterprise and Center of Excellence forums to drive harmonization of standards, templates, lifecycle documentation, and best practices across organizations
Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability
Conduct regular check-ins and annual reviews; coach for performance; provide recognition
Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring
Lead recruiting and hiring and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR
Manage an operating budget and optimize spend against priorities
Inspire and ensure that team leaders are effectively supporting and empowering their individual leaders.

Requirements

What you’ll need

Bachelor's Degree in computer science, math or science with a minimum of 10 year's experience working in relevant field for associated job description (System Validation, Quality Assurance, Testing Lead or related technical role)
3 years people management experience
Demonstrated deep subject matter expertise in relevant discipline System Validation, Quality Assurance, Testing Lead or related technical role.
OR Advanced Degree (Masters or Doctorate) in computer science, math or science with a minimum of 8 years experience working in relevant field for associated job description (System Validation, Quality Assurance, Testing Lead or related technical role) as well as:
3 years people management experience
Demonstrated deep subject matter expertise in relevant discipline System Validation, Quality Assurance, Testing Lead or related technical role.

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days