FDA Computer System Validation (CSV/CSA) Supervisor

Our client is seeking an experienced FDA Computer System Validation (CSV) & Computer System Assurance (CSA) Supervisor to lead validation and compliance initiatives for FDA-regulated clients. This individual will serve as a subject matter expert in CSA, CSV, Data Integrity, and Technology Risk, helping organizations maintain compliant, audit-ready GxP systems while aligning with evolving FDA expectations.This is an opportunity to build and grow an FDA IT Compliance and Validation practice while leading client engagements, mentoring consultants, and driving quality and regulatory excellence.Key ResponsibilitiesLead end-to-end CSA/CSV projects from planning through execution and inspection readinessDevelop validation strategies, requirements traceability matrices, protocols, test scripts, and summary reportsProvide guidance on FDA CSA Guidance, QMSR, 21 CFR Part 11, Annex 11, and GAMP 5Conduct data integrity assessments and support data migration and data quality validation activitiesEvaluate changes to validated systems and determine appropriate validation requirementsSupport SaaS, ERP, and regulated platform implementations including SAP, NetSuite, D365, LMS, and e-signature solutionsAssist with risk assessments, security controls, access management, and IT compliance initiativesLead client-facing validation efforts and coordinate cross-functional project teamsMentor junior consultants and support practice development initiativesParticipate in audits, inspections, deviation management, and change control activitiesRequired Qualifications4+ years of Computer System Validation (CSV), Computer System Assurance (CSA), Data Integrity, or Technology Risk experienceExperience in FDA-regulated environments within pharmaceutical, biotech, medical device, or consulting organizationsStrong knowledge of:FDA CSA GuidanceFDA QMSR21 CFR Part 11Annex 11GAMP 5GxP regulationsExperience validating regulated computerized systems and electronic records/e-signature complianceStrong project leadership, communication, and documentation skillsBachelor's degree in Computer Science, MIS, Engineering, Life Sciences, or related fieldPreferred QualificationsPrevious leadership or supervisory experienceExperience with SAP, NetSuite, Microsoft Dynamics 365, or other regulated ERP platformsKnowledge of cybersecurity frameworks such as NIST or ISO 27001Understanding of IT General Controls (ITGCs), Segregation of Duties (SoD), and security controlsExperience supporting FDA inspections and regulatory audits