System Test and Validation Lead

Job Summary

Drive validation and compliance activities for complex GxP systems as a Senior Consultant, Regulatory, Risk, and Compliance. Supports system validation strategy, audit readiness, CAPA management, and risk-based compliance activities across regulated technology environments. 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, including development of validation approaches for non-deterministic outputs and documentation of AI governance requirements

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, including 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, including Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available principles
• Experience managing CAPA lifecycle activities and supporting inspection readiness for Food and Drug Administration or European Medicines Agency audits
• Experience validating AI/ML-enabled systems, distinguishing deterministic and probabilistic tool behavior, and qualifying or validating automation testing frameworks
• 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