Join EY as a Senior Regulatory Compliance Consultant with expertise in CSV and Veeva QMS. This role involves leading validation, testing, and compliance initiatives for global pharmaceutical clients, ensuring adherence to international regulatory standards. You will drive strategic projects, aiming for operational excellence and business process transformation within a dynamic consulting environment.

Lead validation, testing, and compliance for Veeva QMS and other GxP/non-GxP systems, aligning with global regulations. Define CSV/CSA strategies and integrate validation into Agile models. Oversee AI/ML governance and validation, conduct impact and gap assessments, and author key validation documents. Develop and execute risk-based testing strategies, including functional and user acceptance testing. Advise clients on Veeva QMS quality processes and ensure data integrity and inspection readiness.

A Bachelor's or Master's degree in Biotechnology, Engineering, or a related field is required, along with over 5 years of CSV experience in pharmaceuticals, life sciences, or consulting. Essential skills include a strong understanding of GAMP 5, 21 CFR Part 11, Annex 11, and expertise in CSV documentation. Proven experience in validation and testing of Veeva QMS and GxP systems, alongside familiarity with Agile delivery models and strong stakeholder management skills, are crucial.