Business System Validation Senior Specialist

Job description

Job Description Are you passionate about ensuring data integrity, regulatory compliance, and the successful delivery of business-critical systems? Join our team and play a key role in validating innovative data integration and automation solutions that support high-quality clinical and business operations. The Business System Validation Senior Specialist, GDMS Data Integration and Automation defines and leads enterprise-wide validation strategies to ensure compliance, efficiency, and alignment with organizational objectives. They govern validation frameworks, establish test criteria, and supervise risk-based validation planning to maintain inspection readiness. Responsibilities Validation planning, strategy & readiness Lead end-to-end execution of complex system validation activities with end users across multiple system releases, ensuring alignment with program-level requirements, platform standards, and regulatory expectations Develop advanced validation strategies, risk assessments, coverage models, and test approaches that support large-scale system implementations and cross-functional platform initiatives Support cross-functional system readiness planning by evaluating validation impacts of new features, integrations, platform releases, automation workflows Test execution, defect management & issue resolution Oversee end-to-end test execution for multiple systems or releases, proactively managing issue resolution, escalating risks, and ensuring timely delivery of validation milestones Ensure comprehensive traceability across requirements, design specifications, test cases, and objective evidence throughout the validation lifecycle; identify gaps and drive remediation 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 Provide expert review, guidance, and final approval for validation deliverables across the validation lifecycle (e.g., validation plans, test plans, test scripts, test summaries) Drive adherence to Standard Operating Procedures (SOPs) and regulatory requirements, and contribute to authoring, updating, and harmonizing validation-related processes, templates, and standards Monitor and report validation KPIs (Key Performance Indicators) across projects, identify systemic issues, and lead continuous improvement efforts to enhance validation quality, efficiency, and audit and inspection readiness Serve as a validation subject matter expert during audits and inspections by preparing and presenting validation packages, responding to auditor questions, and ensuring availability of complete, traceable documentation Mentor junior validation staff by providing training, technical guidance, and quality oversight to ensure consistent execution of validation best practices Technical skills Deep understanding of compliance and documentation standards, (e.g., GxP, 21 CFR Part 11, and audit traceability practices) Deep knowledge of validation lifecycle management, risk-based testing, and regulatory compliance frameworks Proficiency in enterprise test management tools and automation platforms Experience in implementing AI-augmented validation frameworks and model governance practices Non-Technical skills Lead day-to-day activities; drive issue triage to closure; coordinate stakeholders Mentor junior analysts on tools, checks, documentation quality, and best practices Prioritize independently; escalate with context, impact, and recommendation Translate technical topics for non-technical stakeholders; gain alignment on trade-offs Manage difficult conversations constructively; negotiate timelines/quality expectations Deliver crisp status, decisions, and blockers; maintain decision logs Enterprise Leadership Skills Decision Making | Identify and understand problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; solve complex problems and apply knowledge of business challenges; able to weigh multiple options and implications Motivation & Inspiration | Communicate effectively, promote teamwork and open discussion, effectively communicate and engage / motivate teammates; inspire others toward higher levels of performance aligned with organization's Purpose and Strategic Framework Coaching & Development | Build self-insight, demonstrate awareness of own strengths and development needs as well as impact of own behavior on others; modify behavior based on self-awareness to improve impact, serve as a resource for collogues, coaches, and guide others Qualifications & experience Non-Degree with a minimum of 8 years of experience working in relevant field for associated job description (System Validation or Testing Lead role) OR [Minimum preferred] Associate's Degree with a minimum of 7 years of experience working in relevant field for associated job description (System Validation or Testing Lead role) OR Bachelor's Degree with minimum of 5 years’ experience working in relevant field for associated job description (System Validation or Testing Lead role) OR Advanced Degree (Masters or Doctorate) with minimum of 2 years’ experience working in relevant field for associated job description (System Validation or Testing Lead role) Additional location(s) Compensation Information: Required Skills: Adaptability, Adaptability, CAPA Management, Clinical Data Management, Clinical Research, Code of Federal Regulations Title 21, Communication, Continuous Improvement Techniques, Data Analysis, Data Quality Assurance, Data Reporting, Data Review, Data Validation, Defects Management, Enterprise Leadership, Good Clinical Practice (GCP), Inspection Readiness, Key Metrics, Key Performance Indicators (KPI) Improvement, Medical Terminology, Project Coordination, Risk-Based Testing, System Implementations, System Validation, Teamwork {+ 8 more} 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 11/14/2026*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.