Join EY as a Senior Consultant in Regulatory Compliance, specializing in CSV and Veeva QMS. You will play a pivotal role in ensuring client compliance with global regulatory standards and driving strategic initiatives for business process transformation. This role offers the chance to build a unique career within a globally supportive and inclusive culture, contributing to a better working world.

As part of the EY – ER - Regulatory Compliance team, you'll understand client needs and deliver solutions aligned with EY guidelines. You'll establish and strengthen relationships, drive projects to completion with high-quality deliverables, and proactively manage risks. Your expertise will be crucial in enhancing operational efficiency and leading internal initiatives, shaping your future with confidence.

Lead validation, testing, and compliance for Veeva QMS modules and other GxP/non-GxP systems, adhering to global regulatory standards. Define and implement CSV/CSA strategies, transitioning to risk-based assurance models and integrating validation into Agile delivery. Oversee AI/ML governance and validation, including model risk management and data integrity. Conduct impact and gap assessments, authoring key validation deliverables such as URS, FRS, Risk Assessments, and summary reports. Develop and execute risk-based testing strategies for Functional Testing and User Acceptance Testing.

Act as a trusted advisor for clients on critical Veeva QMS quality processes, including change management and CAPA. Ensure data integrity and inspection readiness across systems. Coach project teams on documentation expectations and quality standards. You will also be responsible for authoring and reviewing essential project documentation like URS, FRS, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols, Traceability Matrix, and Summary Reports.

We are seeking a Senior Consultant with at least 5 years of experience in Computer System Validation (CSV) within pharmaceutical, life sciences, or consulting environments. A Bachelor’s or Master’s degree in Biotechnology, Engineering, or a related field is required.

Essential skills include strong expertise in CSV/CSA documentation (Gap Analysis, URS, FRS, IQ/OQ/PQ, Risk Assessments, Traceability Matrix, Validation Plans), proven experience with Veeva QMS modules and other GxP systems, and proficiency in developing and executing test scripts for Functional Testing and User Acceptance Testing. Familiarity with Agile delivery models, tools like Jira, Confluence, and test management software (qTest, HP ALM, Xray, Valgenesis) is necessary. Excellent communication, stakeholder management, and client-facing skills are paramount for collaborating effectively across diverse teams.