System Test and Validation Lead

Full-time other-general

Drive validation and compliance activities for complex GxP systems as a Senior Consultant, Regulatory, Risk, and Compliance. This role supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. This role helps clients address emerging validation considerations for AI/ML-enabled systems and automation frameworks. If this sounds exciting, then this team may be the right fit for you! Work you'll do As a Senior Consultant, Regulatory, Risk, and Compliance on the Regulatory, Risk, and Forensic team, you will be responsible for... + Lead end-to-end validation activities for GxP systems, including validation plans, IQ/OQ/PQ protocols, summary reports, user requirements specifications, functional specifications, design specifications, and traceability matrices + Apply risk-based validation principles to assess system impact, classify validation requirements, and support compliance with GAMP 5, 21 CFR Par...