RC - REGULATORY COMPLIANCE - CSV - Senior

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EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – CSV -  Senior   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 will 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 an experienced Senior Consultant (Validation/Tester – Computerized System Validation (CSV)) to lead validation, testing activities and compliance across various regulated and business critical computerized systems for global pharmaceutical clients. The ideal candidate will ensure compliance with global regulatory standards (FDA, EMA, MHRA) and drive strategic initiatives for business process transformation and operational excellence.     Your Key Responsibilities

Lead validation, testing and compliance activities across GxP and non-GxP systems, aligning with global regulatory requirements and client objectives. Define and drive CSV/CSA strategies, enabling transition from traditional validation to risk-based assurance models. Integrate validation and testing into Agile delivery models, ensuring compliance is embedded within iterative development cycles. Oversee AI/ML governance and validation, including model risk management, data integrity, explainability, and compliance with emerging regulatory expectations. Conduct impact assessments, gap assessments, and remediation for legacy and transforming systems. Author and review deliverables including URS, FRS, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols, Traceability Matrix, and Summary Reports. Develop and execute risk-based testing strategies, test scripts for Functional Testing & User Acceptance Testing of GxP systems. Serve as a trusted advisor to clients across critical QMS quality processes, including change management, CAPA, deviations, investigations, and associated documentation, helping deliver compliant solutions and high-quality deliverables. Ensure data integrity and inspection readiness across systems. Coach and guide project teams on proper usage of templates, documentation expectations, and quality standards.

Bachelor’s or Master’s degree in Biotechnology, Engineering, or related field. 5+ years in CSV within the pharmaceutical, life sciences or consulting organizations. Strong understanding of regulatory requirements including, GAMP 5, 21 CFR Part 11, Annex 11. Consulting or client‑facing experience preferred. Excellent communication, documentation, and stakeholder management skills.

Must-Have Skills & Attributes

Strong expertise in CSV/CSA documentation: Gap Analysis, URS, FRS, IQ/OQ/PQ, Risk Assessments, Traceability Matrix, Validation Plans. Proven experience in validation, testing and compliance activities across various QMS modules and other GxP and non-GxP systems. Strong experience in development and execution of test scripts for Functional Testing, User Acceptance Testing of GxP systems. Experience with tools like Jira, Confluence and test management tools like qTest, HP ALM, Xray, Valgenesis, etc. Experience working in Agile delivery models. Strong stakeholder management and client facing