Computer System Validation Lead / Program Manager

Overview As a Computer Systems Validation Lead / Program Manager, you will steer CSV activities for Veeva’s cloud-based quality apps, ensuring compliant validation across releases and patches. You’ll partner with product, SQA, and IT to deliver high-quality, traceable validation deliverables and maintain validated states. This role combines regulatory interpretation with hands-on validation work in a fast-growing SaaS environment. You’ll help life sciences customers accelerate adoption of a unified platform while upholding industry standards and company policies. Compensation / BenefitsMedical, dental, vision, and basic life insuranceFlexible PTO and company paid holidaysRetirement programs1% charitable giving program ResponsibilitiesLead and execute validation for general releases, hot fixes, and revalidationTrack and control validation processes to meet release dates and budgetsProvide regulatory interpretation and technical direction on computer validationCollaborate with Product Team to define clear, testable requirementsCoordinate with cross-functional teams to ensure validated state of systemsEnsure risk-based testing and traceability for all testing activitiesLog and prioritize validation issues; drive closure with Product and SQACreate/update CSV deliverables (IQ/OQ, VPP, VSR, Trace Matrices)Perform independent pre/post execution reviews of validation testsSupport change control as validation technical resource and ensure timely completionConduct validation impact analysis and risk assessments Key requirementsBachelor’s degree in Engineering/Sciences or equivalent3+ years in a CSV roleHands-on validation of enterprise applications (e.g., SAP) in regulated activitiesKnowledge of 21CFR11/Annex 11 and related standards (ISO 9001, ISPE, etc.)Familiarity with Agile, BA, and software testingStrong written/verbal communication, decision-making, and time managementexcellent communicationstrong decision-makingtime managementComputer Systems Validation (CSV)regulatory interpretation and complianceIQ/OQ/VSR/Trace Matrices