Senior CSV Lead - GxP, 21 CFR Part 11, Agile

Posted today

techdigital groupRaritan (NJ)

Computer and Information Systems Managers Computer Systems Design Services

SENIORITY

Manager

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About the role

TechDigital Group seeks a senior CSV lead with 10+ years in Computer System Validation and strong GxP background. You will guide regulatory-aligned validation efforts, enforce 21 CFR Part 11 compliance, and drive agile processes using JIRA and X-Ray/qTest. The role requires strong leadership and change-management skills within a regulated environment. The ideal candidate will manage project artifacts, burn charts, and backlog, ensuring quality and compliance across CSV activities in a dynamic

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