System Test and Validation Lead

About the role

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. It also helps clients address emerging validation considerations for AI/ML‑enabled systems and automation frameworks.

Responsibilities

• 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, developing validation approaches for non‑deterministic outputs and documenting AI governance requirements.

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, dynamic environment.
• Strong interpersonal skills and professional demeanor.
• Ability to meet deadlines and provide clear guidance to others.

Qualifications

• 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 (pharma, biotech, medical device, or clinical).
• Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ protocols, validation plans, summary reports, user requirements specifications, functional specifications, design specifications, and traceability matrices.
• Experience applying 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity requirements (ALCOA+ principles).
• Experience managing CAPA lifecycle activities and supporting inspection readiness for FDA or EMA audits.
• Experience validating AI/ML‑enabled systems and qualifying automation testing frameworks.
• Ability to travel up to 10%.
• Limited immigration sponsorship may be available.
• Preferred: Experience with periodic review programs, cloud/SaaS platforms (Veeva, ServiceNow, Salesforce) in GxP, Agile delivery environments, and AI governance processes.

The Team

The 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. The team leverages advanced data, AI, and emerging technologies with industry insights to bring clarity from complexity and accelerate value creation for clients.

Pay

Estimated compensation range for this remote role is $95,000 to $145,000, with eligibility to participate in a discretionary annual incentive program based on individual and organizational performance.