RC-REGULATORY COMPLIANCE-Digital QMS - BA-Senior

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EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance Senior- QMS Business Analyst (Veeva Vault)   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 We are seeking a Senior Business Analyst – Veeva Vault QMS with proven consulting experience to partner with business and IT teams in designing, implementing, and optimizing Veeva Vault Quality Management Systems (QMS) in regulated (GxP) environments. . You will drive discovery and requirements-to-delivery traceability, shape future-state workflows, support validation and audit readiness (CSV/CSA), and define data migration and integrity approaches for Veeva-enabled quality solutions across the pharmaceutical lifecycle.   Role Overview In this client-facing Business Analyst role, you will lead requirements and process design activities across Veeva Vault QMS programs. You will facilitate workshops, document functional requirements and acceptance criteria, and collaborate with QA/Validation and technical teams to ensure audit-ready delivery aligned with global regulatory standards. You will contribute to successful implementation, integration, and adoption of Veeva Vault Quality solutions in GxP-regulated environments   Your key responsibilities

Lead end-to-end requirements discovery (workshops/interviews) to convert business objectives into epics/user stories, acceptance criteria, and functional specifications. Define As Is/To Be processes, workflow designs, and business rules; maintain requirements baseline, decision log, and end-to-end traceability (requirements → config/design → testing → validation evidence). Own and prioritize the backlog in Jira/ADO, balancing enhancements, defects, compliance needs, and technical debt in an Agile GxP hybrid delivery model. Act as the primary liaison across Business, QA/Validation, IT, and Vendors to align scope, releases, and measurable outcomes. Provide configuration-informed functional leadership for Veeva Vault solutions (objects, lifecycles, workflows, security/roles, document types, metadata). Provide functional leadership across Veeva Vault QMS modules, including: Deviations, CAPA, Change Control, Audit Management, Complaints, Supplier Quality, etc. Perform gap analysis (OOTB vs configuration vs integration) and recommend scalable, compliant solutions; partner with technical teams to translate requirements into Vault configuration and integration designs. Define and support data migration strategy: profiling, field mapping, transformation rules, cleansing, reconciliation, and validation of migrated data; ensure integrity across legacy ↔ Vault and Vault ↔ enterprise flows. Ensure compliance with GxP, 21 CFR Part 11, Annex 11 (where applicable), and GAMP 5; apply a CSV-to-CSA, risk-based mindset. Author/review/coordinate validation deliverables including URS/FRS, risk/impact assessments, Traceability Matrix, and testing/validation evidence