RC-REGULATORY COMPLIANCE-CSV - Veeva Validation-Manager

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EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – CSV - Veeva - Manager 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 will 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 We are seeking an experienced Manager (Validation/Tester – Veeva) to lead validation, testing activities and compliance across various Veeva modules, regulated and business critical computerized systems for global pharmaceutical clients. The ideal candidate will ensure compliance with global regulatory standards (FDA, EMA, MHRA) and drive strategic initiatives for business process transformation and operational excellence.   Your Key Responsibilities

Lead CSA/CSV strategy in collaboration with Governance and risk-based validation approach for the Veeva Vault platform, balancing modern CSA principles (critical thinking, risk-based test coverage) with CSV rigor where required for specific vaults/regulatory contexts. Perform risk assessments on platform changes (configuration, integration, releases) to determine appropriate validation rigor and evidence requirements per change. Define validation/testing evidence requirements in partnership with the QA Engineer role — ensuring test coverage decisions are risk-justified and audit-defensible. Review and approve validation deliverables (validation plans, risk assessments, test evidence, validation summary reports) before closure. Ensure platform changes comply with applicable regulations (21 CFR Part 11, EU Annex 11, GAMP 5) and internal Computerized System Validation policies. Provide compliance guidance to internal Leads and vendor team members on how CSA principles apply to specific configuration/integration scenarios. Support internal/external audits and health authority inspections — act as the platform's validation SME during inspection readiness and response. Partner with QA/Change Management to ensure Change Control records carry appropriate validation justification and evidence. Stay current on evolving CSA guidance (e.g., FDA's CSA draft guidance) and industry practice, advising the CoE on policy updates.

Bachelor’s or Master’s degree in Biotechnology, Engineering, or related field. 8+ years in CSV within the pharmaceutical, life sciences or consulting organizations. Comfortable working with distributed teams across India, Prague, and US time zones. Strong influencing skills to drive practice change (CSV → CSA) across a delivery team that includes multiple other vendor roles.

Must-Have Skills & Attributes

Experience in Computer System Validation, with demonstrated leadership transitioning teams from traditional CSV to CSA practices. Deep knowledge of GAMP 5 (2nd edition), FDA CSA guidance, 21 CFR Part 11, and EU Annex 11. Experience defining risk-based testing/validation strategies that reduce documentation/testing