QMS Implementation-Senior(Veeva/ETQ/Trackwise) (Bengaluru)

QMS Implementation-Senior(Veeva/ETQ/Trackwise) (Bengaluru)

21 Aug
|
EY
|
Bengaluru

21 Aug

EY

Bengaluru

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 (wher

📌 QMS Implementation-Senior(Veeva/ETQ/Trackwise) (Bengaluru)
🏢 EY
📍 Bengaluru

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