System Test and Validation Lead

Deloitte • Raleigh, NC, US • published 2026-09-20 10:54:43.404084

Description

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 Part 11, and data integrity expectations * Drive inspection readiness activities, including gap assessments, mock audits, validation package reviews, and support for regulatory inspections and r...

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