Job Summary

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

EY is seeking a Senior Veeva Vault QMS Developer to support global life sciences clients in designing, configuring, and implementing Veeva Vault Quality Management Systems (QMS) in highly regulated environments. This role is ideal for professionals with deep Veeva Vault technical expertise, strong understanding of GxP compliance, and experience delivering validated, scalable QMS solutions. You will work closely with Quality, IT, Validation, and Business stakeholders to translate quality and compliance requirements into robust Vault configurations that align with global regulatory standards and client quality strategies.

Role Overview

As a Veeva Vault QMS Senior Developer, you will be responsible for configuring, customizing, and deploying Veeva Vault QMS modules, supporting integrations, and ensuring system compliance throughout the validation lifecycle. You will also provide technical leadership within projects and mentor junior resources.

Your key responsibilities

- Configure, customize, and deploy Veeva Vault QMS modules including Deviations, CAPA, Change Control, Audit Management, Quality Risk Management (QRM), Supplier Quality and Complaints, ensuring alignment with client-specific quality processes and regulatory requirements.
- Design and implement workflows, object lifecycles, security roles, and page layouts and reports aligned with client quality processes to support scalable and compliant quality operations.
- Collaborate with Business, Quality, IT,



and Validation teams to translate functional requirements into compliant Vault configurations
- Support data migration activities using Vault Loader and APIs, ensuring data integrity and traceability
- Design and support system integrations between Veeva Vault and enterprise systems (SAP, LIMS, MES, DMS, etc.)
- 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.
- Mentor junior developers and support knowledge sharing and capability building within the team.

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 (objects, workflows, lifecycles, security, reporting), with a strong focus on Quality Management System (QMS) modules.
- Robust understanding of QMS processes (Deviation, CAPA, Change Control, Audit, Complaints)
- Proficiency with Vault Loader, Veeva APIs, and release management practices
- GAMP 5 methodology and system development life cycle (SDLC)
- Ability to collaborate with cross-functional teams (QA, IT, Digital, Commercial, 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
- 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 creative 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
- Contribution to process optimization, accelerators, or reusable assets
- Exposure to AI/automation usage in regulated systems and governance considerations

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Sr RC-REGULATORY COMPLIANCE-QMS - CA-Veeva Professional (Kolkata)
🏢 EY
📍 Kolkata