Veeva Vault-Senior/Manager

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 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, 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