RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Senior - Veeva Vault QMS

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 –Senior - Veeva Vault QMS

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 senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you'll 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 a skilled and client-focused Veeva Vault QMS Senior Developer to join our team and play a key role in delivering high-impact solutions for life sciences clients. This opportunity is ideal for professionals who combine deep technical expertise with strong consulting capabilities, and who thrive in regulated environments.

Role Overview

As a Veeva Vault QMS Senior Developer, you will be responsible for configuring, customizing, and deploying Veeva Vault Quality applications (QRM, CAPA, Change Control, Complaints) in client environments. You will collaborate with cross-functional teams to translate business requirements into scalable configurations, support system integrations, and ensure compliance with global regulatory standards.

Your Key Responsibilities

• Configure, customize, and deploy Veeva Vault QMS modules including Quality Risk Management (QRM), CAPA, Change Control, and Complaints, ensuring alignment with client-specific quality processes and regulatory requirements.
• Design and implement workflows, object lifecycles, security roles, and page layouts within Vault QMS to support scalable and compliant quality operations.
• Engage with cross-functional teams (Quality, IT, Business) to elicit, analyze, and translate business requirements into robust Vault configurations and enhancements.
• Lead and support data migration and system integration efforts, ensuring seamless connectivity between Veeva Vault and other enterprise platforms (e.g., ERP, LIMS, Document Management Systems).
• Author and maintain comprehensive system documentation, including configuration specifications, design documents, validation protocols (IQ / OQ / PQ), and user guides.
• Provide expert-level troubleshooting and impact analysis, resolving system issues efficiently while minimizing disruption to business operations.
• Ensure system compliance with global regulatory standards including GxP, CSV / CSA, and 21 CFR Part 11, incorporating best practices in validation and audit readiness.
• Participate in release management activities, including change impact assessments, regression testing, and deployment planning across sandbox and production environments.
• Act as a trusted advisor to clients, offering strategic guidance on Vault QMS capabilities, roadmap planning, and optimization opportunities.

Qualifications :

Must-Have Skills & Attributes

Good-to-Have Skills & Attributes

What We Look For

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 :

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.

Skills Required

Csv, Capa, Change Control, 21 Cfr Part 11, Csa, Agile, Scrum, Complaints