REGULATORY COMPLIANCE-CSV - GxP AI-Val Testing -Senior

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EY- GDS Consulting Enterprise Risk (ER) Regulatory Compliance Senior GxP AI Validation/Testing

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

The opportunity

We are seeking a highly experienced and detail-oriented senior with strong expertise in validating AI/ML models, Generative AI (GenAI) systems, and multiagent workflows within GxP-regulated and quality-critical environments. The ideal candidate will ensure the reliability, fairness, robustness, and regulatory compliance of AI solutions while supporting cross-functional teams in designing, testing, and maintaining production-ready, inspection-ready AI systems.

This role is responsible for leading AI validation and testing activities across the full model lifecycle, including model development, training, testing, deployment, and post-deployment monitoring, in alignment with GxP principles, risk-based validation, and data integrity expectations. The consultant will play a key role in embedding Responsible AI, quality-by-design, and governance-by-design practices, enabling the safe, trustworthy, and explainable use of AI and agent-based solutions in regulated life sciences and pharmaceutical contexts.

Your key responsibilities

• Lead the validation strategy for AI/ML and GenAI-enabled business solutions, ensuring compliance with GxP, CSV, CSA, risk management, and applicable regulatory expectations.
• Author and maintain Validation Plans, Validation Strategies, Traceability Frameworks, Acceptance Criteria, and Validation Summary Reports for AI-integrated platforms and use cases.
• Define risk-based testing approaches for AI-enabled user workflows, focusing on functional suitability, business process integrity, intended use verification, and compliance requirements.
• Oversee front-end validation activities for AI-powered applications, ensuring user interactions, outputs, workflows, and decision-support functionalities perform as intended across business scenarios.
• Establish validation deliverables throughout the AI solution lifecycle, including requirement review, test planning, change assessment, release readiness reviews, and post-deployment monitoring support.
• Provide compliance oversight for AI solution delivery, ensuring validation evidence, documentation, and audit trails are complete, traceable, inspection-ready, and aligned with organizational quality standards.
• Collaborate with Product Owners, Business Stakeholders, Data Scientists, Engineers, and Quality teams to translate business requirements into testable validation and compliance objectives.
• Leverage observability and monitoring frameworks to assess AI system behaviour trends, identify deviations impacting validated state, and support ongoing compliance assessments.
• Coordinate defect triage, impact assessment, root cause discussions, and remediation activities while ensuring appropriate documentation and closure in accordance with quality processes.
• Manage release governance and stakeholder communications by facilitating validation reviews, compliance sign-offs, deployment readiness assessments, status reporting, and executive-level updates throughout the implementation lifecycle.

Qualifications

• Bachelor’s or master’s degree in Life Sciences, Engineering, or related field.
• 5+ years of experience in AI/ML, GenAI, software testing, validation, or quality engineering roles.
• Experience creating user stories, test scripts, validation plans, or AI solution prototypes.
• Exposure to cloud ecosystems such as Azure, AWS, or GCP.
• Consulting or client-facing expe…