Validation Lead

IM Regulatory Validation LeadExperience: 7+YearsLocation: Raritan, New Jersey, HybridNote: U.S. work authorization required (USC or Green Card on W‐2 payroll only).RoleWe are looking for an experienced Validation Lead to take end‐to‐end ownership of validation activities for a Unified Regulatory Platform (URP) built on Veeva and AWS cloud stack.Key Responsibilities:Act as the single point of accountability for all validation deliverablesAuthor key validation documents including: Validation/Compliance Plan, Validation Reports, Requirements Traceability Matrix (RTM), Data Flow Maps, Change Controls.Define and execute validation strategies for projectsProvide guidance on SDLC and CSV best practicesSupport audit readiness and application lifecycle managementLead change control processes and coordinate go‐live activitiesCollaborate with and guide cross-functional teamsRequired Skills & Experience:7–9 years of experience in:Computer System Validation (CSV)Quality Management or Business Analysis in GxP environmentsStrong understanding of GxP regulations, GCP, and FDA 21 CFR Part 11Hands-on experience with validation and testingProficiency in tools such as JIRA, qTest, ServiceNow (SNOW)Solid knowledge of Agile/iterative development methodologiesStrong skills in Risk management & mitigation, Project planning & execution, and Analytical thinking & problem-solvingQualifications:Bachelor's degree in Technology or EngineeringPreferred: Prior experience with Johnson & Johnson (J&J) environments