Associate Director, Business System Validation

Job description

Job Description The Associate Director, Business Systems Validation leads validation teams across multiple studies and programs. The individual manages performance, workload, and development planning for direct reports. Responsibilities: Validation planning, strategy & readiness Oversee testing and validation delivery (including planning, project management, etc.) acting as the primary validation leader across clinical databases, platform technologies, data pipelines, and automation tools, ensuring consistency, regulatory compliance, and adherence to security and data protection requirements Lead system readiness assessments and cross-team alignment for higher-risk or multi-system initiatives, ensuring end-to-end validation coverage across integrations, workflows, and dependent systems 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 Lead root cause analysis (RCA) and corrective/preventive action (CAPA) activities for complex issues identified during testing; guide teams on risk mitigation and quality improvements Documentation, compliance & continuous improvement Define, enhance, and maintain enterprise validation frameworks, standards, and templates in alignment with policies, governance requirements, and Center of Excellence guidance Oversee audit and inspection readiness for assigned systems and programs, ensuring validation packages, documentation, and objective evidence meet internal QA expectations and external regulatory requirements Serve as a senior subject matter expert for validation best practices, risk-based approaches, security controls, data integrity principles, and compliance with SOPs (Standard Operating Procedures) and regulations, and corporate policies Drive strategic adoption of automation frameworks, AI-enabled testing solutions, and validation process improvements to increase efficiency, traceability, and operational scalability Provide leadership, coaching, and technical oversight to junior validation staff and project teams to strengthen competencies, elevate documentation quality, and ensure consistent application of validation standards Collaborate with the Center of Excellence and platform governance bodies to ensure consistent implementation of enterprise validation models, security requirements, lifecycle documentation, and audit-ready processes Lead the ongoing updating, harmonization, and maintenance of procedural documents, including SOPs, validation standards, and lifecycle documentation, serving as an enterprise subject matter expert 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. Inspire and ensure that team leaders are effectively supporting and empowering their individual leaders. Technical skills Deep understanding of compliance and documentation standards (e.g., GxP, 21 CFR Part 11, and audit traceability practices) Expert understanding of validation lifecycle management, test governance, and regulatory compliance Expertise in test automation frameworks, AI-assisted validation tools, and continuous testing within DevOps pipelines Deep understanding of risk-based validation, documentation standards, and audit traceability Non-technical skills: Strong ability to lead programming teams in a matrixed, global organization while ensuring delivery excellence Demonstrated success in coaching, developing, and performance-managing high-performing individuals Builds strong partnerships across technical, business, and quality functions to enhance collaboration and deliver integrated outcomes Balances business needs, resource capacity, and compliance requirements to make sound operational decisions Guides and reviews work across teams/geographies; builds capability and consistency; fosters inclusive, high-trust culture Engages vendor, data, and industry forums; represents team professionally and credibly under pressure; maintains resilience and composure Operates effectively in ambiguity; drives consensus across functions; steers process/technology improvements Strong understanding of operations of functions Enterprise Leadership Skills: Execution Excellence | Is results-focused per compliance standards; sets ambitious expectations for accomplishment and ensures others contribute to org strategies by focusing them on the most critical priorities; translates departmental goals into clear expectations Coaching & Development | Manages individual contributors and/or supervisors, provides technical guidance, and develops others through coaching, feedback, and guidance Entrepreneurship | Embraces patient customer focus, ensuring that internal or external customer perspective is the driving force behind strategic priorities, business decisions, org processes, and individual activities; crafts and implements service practices that meet customers' and own organization needs Qualifications & experience: Bachelor's Degree 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: 2 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 4 years experience working in relevant field for associated job description (System Validation, Quality Assurance, Testing Lead or related technical role). 2 years people management experience. Demonstrated deep subject matter expertise in relevant discipline System Validation, Quality Assurance, Testing Lead or related technical role. Headcount responsibility: 6 to 8 Required Skills: Clinical Data Management, Data Analysis, Data Validation, Operational Decisions, Organizational Performance Management, People Leadership, Project Management, System Validation Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 08/10/2026*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 late