RC-REGULATORY COMPLIANCE-REGULATORY COMPLIANCE-Senior

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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:

Bachelor's 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

5–7 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 solutionsStrong communication and presentation skillsExperience in IT project management and validation planningAbility to troubleshoot application issues and recommend solutionsFamiliarity with change control, deviation handling, and CAPA processesProven ability to mentor junior resourcesExperience in training and cross-skilling resourcesStrong teamwork and collaboration mindsetVeeva associate administrator level certification

Good-to-Have Skills & Attributes

Exposure to business development activities and client engagement strategiesGood knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11)Ability to create innovative insights and contribute to thought leadershipExperience in process optimization and operational efficiency initiativesAbility to align technology with business transformation goalsHigh attention to detail and analytical thinkingAdaptability to changing regulatory and business environmentsStrong 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 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 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:

Support, coaching and feedback from some of the most engaging colleagues aroundOpportunities to develop new skills and progress your careerThe 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.

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