Director, Business System Validation - Hybrid

MSD•Rahway, NJ

1d•$173,200 - $272,600•Hybrid

About The Position

The Director, Business Systems Validation External / Automation provides strategic leadership and direction to validation teams within an assigned geography. They oversee performance management, organizational capability building and process optimization. They partner with other leaders on workforce strategy, talent development, and alignment on enterprise Business Validation goals.

Requirements

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) 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.
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.
Automated Testing
Budget Management
Clinical Data Management
Data Integrity
Data Validation
Decision Making
Decommissioning
Good Clinical Practice (GCP)
Key Performance Indicators (KPI)
Mentoring Staff
People Leadership
Stakeholder Relationship Management
Strategic Thinking
System Validation
User Acceptance Testing (UAT)

Nice To Haves

Advanced understanding of compliance and documentation standards (e.g., GxP, 21 CFR Part 11, and audit traceability practices)
Deep experience in validation governance and enterprise risk management
Strong understanding of data architecture, data lifecycle governance, and system interoperability
Advanced knowledge of automation and AI testing frameworks, including validation of ML models and automated testing pipelines
Proven experience overseeing audit readiness and regulatory inspections across global environments
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, different, 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
Strong understanding of operations of functions

Responsibilities

Validation planning, strategy & readiness: Define and lead validation strategy across domains and platforms, ensuring alignment with our company SDLC (Software Development Life Cycle) 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. Lead strategic alignment of validation processes with major platform roadmaps, data modernization initiatives, and cross-functional technical delivery plans.
Test execution, defect management & issue resolution: Proactively identify systemic validation gaps, assess compliance risks, and drive corrective and preventive actions to improve validation quality, audit preparedness, and operational performance. Drive functional-level operating model improvements based on learnings and findings.
Documentation, compliance & continuous improvement: 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. Oversee process documentation & completeness associated with archiving & decommissioning processes.
People management: 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. Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs. Manage an operating budget and optimize spend against priorities. Inspires and ensures that team leaders are effectively supporting and empowering their individual leaders.
Technical skills: Advanced understanding of compliance and documentation standards (e.g., GxP, 21 CFR Part 11, and audit traceability practices). Deep experience in validation governance and enterprise risk management. Strong understanding of data architecture, data lifecycle governance, and system interoperability. Advanced knowledge of automation and AI testing frameworks, including validation of ML models and automated testing pipelines. Proven experience overseeing audit readiness and regulatory inspections across global environments.
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, different, 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. Strong understanding of operations of functions.
Enterprise Leadership Skills: Strategic Planning | Plans strategically by gathering information and identifying key issues, dependencies, and relationships critical to achieving long-range goals; commits to a course of action after developing and evaluating alternatives based on facts, available resources, constraints, and organizational values. Networking & Partnerships | Cultivates networks and partnerships by initiating and maintaining strategic relationships with stakeholders and potential partners inside and outside the organization who provide the information, ideas, expertise, and influence needed to deepen understanding of business issues and achieve business goals. Change Catalyst | Leads change by driving the organizational and cultural shifts needed to achieve strategic priorities; catalyzes new approaches to improve results by evolving culture, systems, and services; helps others overcome resistance and adopt change.