Skills
GxP system validation
IQ/OQ/PQ protocols
Risk-based compliance
About the Role
We’re seeking a System Test & Validation Lead to drive validation and compliance activities for complex GxP systems. In this Senior Consultant role on our Regulatory, Risk, and Forensic team, you’ll help clients build validation strategies, maintain audit readiness, and manage CAPA in regulated technology environments.
You’ll also support emerging validation considerations for AI/ML-enabled systems and automation frameworks—ensuring clients can confidently meet evolving regulatory expectations.
Responsibilities
- Lead end-to-end validation for GxP systems, including validation plans, IQ/OQ/PQ protocols, summary reports, and required documentation
- Apply risk-based validation to evaluate system impact and determine appropriate validation scope and classification
- Support audit readiness through compliant, well-organized validation records and traceable evidence
- Contribute to CAPA management by identifying root causes, supporting corrective actions, and tracking effectiveness
- Develop and maintain user requirements, functional specifications, design specifications, and traceability matrices
- Assess system and process changes to ensure ongoing compliance across regulated technology environments
Requirements
- Strong experience leading validation activities for GxP systems (IQ/OQ/PQ, validation documentation, and traceability)
- Working knowledge of regulatory expectations related to validation, compliance, and audit readiness
- Demonstrated ability to apply risk-based approaches to validation planning and execution
- Experience supporting CAPA processes and validation-related investigations
- Familiarity with validation considerations for AI/ML-enabled systems and/or automated frameworks is a plus
Benefits
- Opportunity to work with regulated technology teams and help shape validation strategies for emerging systems
- Collaborate with a dedicated Regulatory, Risk, and Forensic team focused on audit-ready outcomes
- Meaningful impact through improved compliance, documentation quality, and risk management
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