RC-REGULATORY COMPLIANCE-QMS - CA-Veeva-Senior

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

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.

• 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.

• 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.

• 57 years of hands-on experience in Veeva Vault development (objects, workflows, lifecycles, security, reporting), with a strong focus on Quality Management System (QMS) modules.
• Strong 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

• 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