Senior Regulatory Compliance Consultant - Veeva QMS Validation & Testing

Ernst & Young LLP ( EY India ); Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

EY India seeks an experienced Senior Consultant (Validation/Tester – Veeva QMS) to lead validation, testing, and compliance for global pharmaceutical clients. The candidate will ensure compliance with global regulatory standards (FDA, EMA, MHRA) and drive strategic initiatives for process transformation and operational excellence.

The role requires strong expertise in Veeva QMS, CSV/CSA, and Agile delivery within GxP environments, with client-facing responsibilities and collaboration across IT,

Qualifications

• 5+ years in CSV within pharma, life sciences or consulting.
• Strong understanding of GAMP 5, 21 CFR Part 11, Annex 11.
• Consulting or client-facing experience preferred.
• Excellent communication, documentation, and stakeholder management skills.
• Experience with Veeva QMS is required.

Responsibilities

• Lead validation, testing and compliance activities across Veeva QMS modules and other GxP systems.
• Define and drive CSV/CSA strategies aligned with regulatory requirements.
• Integrate validation into Agile delivery models with traceability.
• Oversee AI/ML governance and validation including data integrity and explainability.
• Prepare URS, FRS, IQ/OQ/PQ, risk assessments, and validation reports.

Skills

Veeva QMS

CSV/CSA

GxP compliance

Agile delivery

Regulatory knowledge

Education

Bachelor's or Master's in Biotechnology/Engineering

Tools

Jira

Confluence

qTest

HP ALM

Xray

Valgenesis

Job description

RC – REGULATORY COMPLIANCE – CSV – Veeva – Senior

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.

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

The Opportunity

We are seeking an experienced Senior Consultant (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 acrossVeeva QMS modules and other GxP and non-GxP systems, aligning with global regulatory requirements and client objectives.
• Define and driveCSV/CSA strategies, enabling transition from traditional validation torisk-based assurance models.
• Integrate validation and testing intoAgile delivery models, ensuring compliance is embedded within iterative development cycles.
• OverseeAI/ML governance and validation, including model risk management, data integrity, explainability, and compliance with emerging regulatory expectations.
• Conductimpact assessments, gap assessments, and remediationfor 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 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.
• 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 acrossVeeva 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 other QMS platforms such as 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.
• 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

EY | Building a better working world EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets.

Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow.

EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions.

Fueled by sector insights, a globally connected, multi‑disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.