Join EY's GDS Consulting team as a Senior Regulatory Compliance professional specializing in GxP AI Validation and Testing. This role offers the opportunity to build a unique career within a global, inclusive culture. You will enhance your skills by working on innovative projects and contributing to EY's mission of building a better working world.

This position focuses on ensuring the reliability, fairness, robustness, and regulatory compliance of AI/ML models and Generative AI systems within GxP-regulated environments. You will be instrumental in supporting cross-functional teams to deliver production-ready, inspection-ready AI solutions.

Embrace an opportunity to be part of a market-leading, multidisciplinary team of over 1400 professionals. EY provides integrated global transaction business services, offering unparalleled opportunities to work with leading businesses across diverse industries worldwide. Leverage continuous learning, coaching, and practical experience to shape your personal development.

Lead the validation strategy for AI/ML and Generative AI solutions, ensuring adherence to GxP, CSV, CSA, and risk management expectations. Author essential validation documents including plans, strategies, traceability frameworks, acceptance criteria, and summary reports for AI-integrated platforms.

Define and implement risk-based testing approaches for AI-enabled workflows, focusing on functional suitability, business process integrity, and compliance requirements. Oversee front-end validation for AI-powered applications, confirming intended functionality across various business scenarios.

Establish comprehensive validation deliverables throughout the AI solution lifecycle, from requirement reviews to post-deployment monitoring. Provide critical compliance oversight, ensuring all validation evidence, documentation, and audit trails are complete and inspection-ready. Collaborate closely with Product Owners, Data Scientists, Engineers, and Quality teams to translate business needs into actionable compliance objectives.

Utilize observability frameworks to monitor AI system behavior, identify deviations, and support ongoing compliance assessments. Coordinate defect triage, impact analysis, and remediation efforts, ensuring proper documentation. Manage release governance, stakeholder communications, and provide executive-level updates throughout the implementation process.

We seek a seasoned professional with a Bachelor's or Master's degree in Life Sciences, Engineering, or a related field, complemented by over 5 years of experience in AI/ML, GenAI, software testing, validation, or quality engineering.

Essential skills include a strong command of Computer System Validation (CSV), Computer Software Assurance (CSA), GAMP 5, and risk-based validation methodologies. Proven experience in authoring key validation documents and leading validation activities for AI/ML-enabled initiatives is crucial.

Demonstrate expertise in defining risk-based testing strategies and understanding AI/ML system lifecycles, including data ingestion, model deployment, and operational controls. Familiarity with release and defect management within validated environments is expected. Excellent stakeholder management and communication skills are vital for collaborating effectively across diverse teams. Experience in client-facing roles and IT project management is preferred.

Additional desirable skills include familiarity with cloud ecosystems (Azure, AWS, GCP), Generative AI concepts, AI observability frameworks, and AI validation regulations. The ability to troubleshoot application issues and recommend solutions, along with experience in mentoring junior staff, will be highly valued.