IT CSV Manager

IT CSV Manager will develop the IT Computer System Validation strategy for GxP IT systems, oversee validation and compliance across the full system lifecycle, and manage the IT CSV Training program. The role partners with Corporate QA to implement CSV processes, creates SOPs and WIs for risk management, validation, and change control, oversees validation of IT GxP systems, coordinates vendor audits/qualification, represents IT during internal and external audits, and ensures training program compliance. Candidates should have a Bachelor’s degree in IT or related field, 5–7 years of experience in developing/implementing CSV practices across manufacturing operations and ERP/Quality Lab systems, strong CFR Part 11 and Annex 11 knowledge, cross-functional collaboration, and the ability to train users; must be 18+, able to pass drug/background checks, and authorized to work in the US without visa sponsorship. This is a full-time, remote-friendly role based in the US with benefits including health/dental/vision, 401k, paid time off, and occasional overtime.