RC-REGULATORY COMPLIANCE-QMS - CA-Veeva-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 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