RC-REGULATORY COMPLIANCE-CSV-Veeva-Staff

EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – CSV - Veeva QMS - Staff 

At EY, we’re all in to shape your future with confidence. 

We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go.  Join EY and help to build a better working world.

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 Staff 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 Staff (Validation/Tester – Veeva QMS) to lead validation, testing activities and compliance across various Veeva QMS modules, 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 Veeva QMS modules and other 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.
• 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 Veeva QMS and other GxP systems.
• Serve as a trusted advisor to clients across critical Veeva QMS quality processes, including change management, CAPA, deviations, investigations, and associated documentation, helping deliver compliant solutions and high-quality deliverables.

Qualifications

• Bachelor’s or Master’s degree in Biotechnology, Engineering, or related field.
• 2+ 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 And 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 Veeva 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 And Attributes

• Exposure to business development activities and client engagement strategies.
• Experience with other QMS platforms such as TrackWise, MasterControl and ETQ Reliance.
• High attention to detail and analytical thinking.
• Familiarity with emerging regulatory trends, such as CSA or digital validation approaches.

Preferred Certifications

• Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
• Any Veeva Quality certification.

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