EY- GDS Consulting Enterprise Risk-ERRegulatory Compliance Senior/manager

Role Overview

As a Veeva Vault Quality/RIM/Clinical Senior Developer, you will be responsible for configuring, customizing, and deploying Veeva Vault Quality, Clinical, RIMS applications 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.
- Configure, customize, and deploy Veeva Vault RIMS applications including knowledge of modules like submission management, submission archival etc.
- Configure, customize, and deploy Veeva Vault Clinical (CTMS,ETMF) in client environments
- Design and implement workflows, object lifecycles, security roles, and page layouts within Vault Suite 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, MES, 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 And Attributes

- 3–10 years of hands-on experience in Veeva Vault development, with a robust 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, 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
- 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 And 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

📌 Veeva Vault-Senior(RIM implementation/configuration) (Bengaluru)
🏢 EY
📍 Bengaluru