System Test and Validation Lead

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 responses


* Lead CAPA activities for validation findings, including root cause analysis, effectiveness checks, closure documentation, and tracking of open compliance actions


* Validate AI/ML-enabled GxP systems and automation testing frameworks, including development of validation approaches for non-deterministic outputs and documentation of AI governance requirements

A successful candidate would possess these skills:


* Ability to work independently and collaborate as part of a team


* Effective written and verbal communication skills


* Meticulous attention to detail and quality of work product


* Ability to build and sustain professional relationships


* Ability to lead projects or workstreams


* Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment


* Strong interpersonal skills and professional demeanor


* Ability to meet deadlines


* Ability to provide clear guidance to others

The Team

Our Deloitte Regulatory, Risk & Forensic team helps client leaders translate multifaceted risk and an evolving regulatory environment into defensible actions that strengthen, protect, and transform their organization.

Join our team and use advanced data, AI, and emerging technologies with industry insights to help clients bring clarity from complexity and accelerate their path to value creation.

Qualifications

Required:


* Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment, including pharma, biotech, medical device, or clinical


* Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ protocols, validation plans, summa...