RC - REGULATORY COMPLIANCE - CSV - Senior

RC - REGULATORY COMPLIANCE - CSV - 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 – 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.

 

 

Qualifications

 

• 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 skills, with ability to collaborate across business, IT and quality teams
• Strong project management, problem solving and communication skills

 

 

Good-to-Have Skills & Attributes

 

• Exposure to business development activities and client engagement strategies.
• Automation testing experience with tools like Tricentis Tosca, Selenium, Leapwork, etc. is an added advantage.
• Experience with QMS platforms such as Veeva, TrackWise, MasterControl and ETQ Reliance.
• Understanding of AI/ML lifecycle, governance and validation skills.
• Ability to align technology with business transformation goals.
• 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

 

• Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
• Information Security or Risk Management certifications.

 

 

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, we’re 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 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