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

EY- GDS Consulting Enterprise Risk - ER Regulatory Compliance Senior - Veeva Vault QMS

At EY were all in to shape your future with confidence.

Well 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 line with our commitment to quality youll 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:

• Bachelors degree in computer science Information Technology or a related technical discipline.
• Proven proficiency in configuring the Veeva Vault platform including objects fields roles workflows lifecycles and reporting tools.
• Familiarity with Veeva APIs Vault Loader and other integration tools for data migration and system interoperability.
• Experience working in Agile/Scrum environments contributing to iterative development and continuous improvement.
• Solid understanding of GxP compliance CSV/CSA methodologies and 21 CFR Part 11 requirements in validated environments.
• Strong analytical and problem-solving abilities with excellent communication client interaction and documentation skills.

Must-Have Skills & Attributes

• 57 years of hands-on experience in Veeva Vault development with a strong focus on Quality Management System (QMS) modules.
• GAMP 5 methodology and system development life cycle (SDLC)
• Ability to collaborate with cross-functional teams (QA IT Manufacturing Labs)
• Experience in client-facing roles managing expectations and delivering solutions
• Strong communication and presentation skills
• Experience in IT project management and validation planning
• Ability to troubleshoot application issues and recommend solutions
• Familiarity with change control deviation handling and CAPA processes
• Proven ability to mentor junior resources
• Experience in training and cross-skilling resources
• Strong teamwork and collaboration mindset
• Veeva associate administrator level certification

Good-to-Have Skills & Attributes

• Exposure to business development activities and client engagement strategies
• Good knowledge of GxP regulations (FDA 21 CFR Part 11 EU Annex 11)
• Ability to create innovative insights and contribute to thought leadership
• Experience in process optimization and operational efficiency initiatives
• Ability to align technology with business transformation goals
• High attention to detail and analytical thinking
• Adaptability to changing regulatory and business environments
• Strong problem-solving and decision-making abilities

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 were 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 thats right for you