Senior Validation Consultant - Computerized System Validation (CSV)

RC - REGULATORY COMPLIANCE - CSV - Jama Connect System - Senior At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Validation Consultant (Jama Connect System) – 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 Consultant 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 Validation Consultant – Computerized System Validation (CSV) to lead validation and compliance for JAMA connect system 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 Support validation and compliance activities across GxP and non-GxP systems, aligning with global regulatory requirements and client objectives. Hands-on experience in validating Jama Connect and managing end-to-end requirements lifecycle, traceability, and CSV documentation (URS, FRS, Traceability Matrix) while ensuring adherence to GxP and regulatory compliance standards. Define and drive CSV/CSA strategies, enabling transition from traditional validation to risk-based assurance models. Integrate validation into Agile delivery models, ensuring compliance is embedded within iterative development cycles. 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. Ensure data integrity and inspection readiness across systems. Coach and guide project teams on proper usage of templates, documentation expectations, and quality standards. Qualifications Bachelor’s or Master’s degree in Biotechnology, , Engineering, or related field. 4-7 years in performing CSV activities 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 Hands-on experience with Jama Connect, including requirements management, traceability, and validation within regulated (GxP) environments. Strong Expertise in CSV/CSA documentation: Gap Analysis, URS, FRS, IQ/OQ/PQ, Risk Assessments, Traceability Matrix, Validation Plans. Experience working in Agile delivery models Understanding of AI/ML lifecycle, governance and validation skills Strong stakeholder management and client facing skills, with ability to collaborate across business, IT and quality teams Strong problem solving and communication skills Good-to-Have Skills & Attributes Exposure to business development activities and client engagement strategies. High attention to detail and analytical thinking. Familiarity with emerging regulatory trends, such as CSA or digital validation approaches. Adaptability to changing regulatory and business environments. Preferred Certifications ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA). Information Security or Risk Management certifications. What we look for Professionals with experience in Jama Connect, including validation, requirement traceability, and exposure to Jama Connect implementation within regulated environments, will be preferred. 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, we’re dedicated to helping our clients, from start–ups 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 that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today. Experience Level Senior Level