RC-REGULATORY COMPLIANCE-AI Tester-Senior

EY- GDS Consulting Enterprise Risk - ER Regulatory Compliance Senior AI Tester

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 line with our commitment to quality youll 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 detailoriented AI Testing Specialist with strong expertise in validating AI/ML models GenAI systems and multiagent workflows. The ideal candidate will ensure the reliability fairness and performance of AI solutions while supporting crossfunctional teams in developing testing and maintaining productionready AI systems. This role includes leading AI validation activities across the model lifecycle driving Responsible AI practices and enabling safe and trustworthy deployment of advanced AI capabilities. It also involves strategic stakeholder engagement experimentation support and contributing to the continuous improvement of AI quality and governance frameworks.

Your key responsibilities

• Support development of AI/ML and Agentic AI strategies by providing analysis validation insights and readiness assessments.
• Contribute to the creation of AI roadmaps adoption frameworks and testing standards.
• Design and execute test plans test cases and validation scripts for ML models LLMs GenAI components and agentic workflows.
• Perform functional nonfunctional robustness drift bias and safety testing across AI systems.
• Validate model outputs assess model performance and ensure alignment with Responsible AI and compliance guidelines.
• Support governance activities including documentation traceability risk logs and audit preparedness.
• Gather business and technical requirements and translate them into clear user stories acceptance criteria workflows and testable scenarios.
• Collaborate with Product Owners and AI/ML teams to ensure model behaviour aligns with business objectives.
• Develop demos prototypes and accelerators to showcase AI capabilities and validate hypotheses.
• Support PoCs rapid experimentation and iterative solution refinement.
• Lead AI testing workstreams and coordinate with Data Science Engineering Cloud Compliance and Design teams.
• Prepare and deliver presentations insights risk assessments and recommendations to stakeholders.

Qualifications:

• Bachelors or masters degree in Life Sciences Engineering or related field.
• 3 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 clientfacing experience preferred.
• Excellent communication documentation and stakeholder management skills.

Must-Have Skills & Attributes

• Strong understanding of ML models LLMs GenAI workflows agentic systems and evaluation techniques.
• Experience designing test cases user stories and acceptance criteria for AI/MLbased systems.
• Ability to validate AI outputs evaluate accuracy detect bias and assess model reliability under varied conditions.
• Handson skills in building prototypes test harnesses and demo environments.
• Strong stakeholder management analytical thinking and structured communication skills.
• Familiarity with version control prompt engineering fundamentals and AIassisted testing tools is preferred.
• Strong knowledge of GxP regulations (FDA 21 CFR Part 11 EU Annex 11)
• GAMP 5 methodology and system development life cycle (SDLC)
• CSV documentation: URS FRS IQ/OQ/PQ Traceability Matrix Validation Plans
• Understanding of data integrity principles and electronic records/e-signatures compliance
• Ability to collaborate with cross-functional teams (QA IT Manufacturing Labs)
• Experience in client-facing roles managing expectations and delivering solutions
• Strong communication and presentation skills
• Experience in IT project management and validation planning
• Ability to troubleshoot application issues and recommend solutions
• Familiarity with change control deviation handling and CAPA processes
• Proven ability to mentor junior staff and lead validation teams
• Experience in training and cross-skilling resources
• Strong teamwork and collaboration mindset

Good-to-Have Skills & Attributes

• Exposure to business development activities and client engagement strategies
• Ability to create innovative insights and contribute to thought leadership
• Understanding of market trends and competitor landscape
• Experience in process optimization and operational efficiency initiatives
• Ability to align technology with business transformation goals
• High attention to detail and analytical thinking
• Adaptability to changing regulatory and business environments
• Strong problem-solving and decision-making abilities

Ideally youll also have

• Certified Software Quality Engineer (CSQE) Certified Software Quality Assurance (CSQA)
• ISO 9001:2015 Lead Auditor Quality Auditor Certification (CQA)
• Information Security or Risk Management certifications
• Veeva Associate Administrator Certification and/or equivalent platform credentials.

What we look for

• A Team of people with commercial acumen technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading multi-disciplinary team of 1400 professionals in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

What working at EY offers

At EY were dedicated to helping our clients from startups to Fortune 500 companies and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus we offer:

• Support coaching and feedback from some of the most engaging colleagues around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way thats right for you