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EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Manager- ScrumMaster with GxP Validation Experience
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 Manager 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 chance
We are seeking a highly skilled CSV & Scrum Delivery Manager with strong expertise in GxP system validation and Agile delivery activities.



The ideal candidate will ensure compliance with global regulations (FDA, EMA, MHRA), support cross‑functional teams, and drive the implementation and maintenance of validated systems across the pharmaceutical lifecycle, including Veeva Vault Quality, Clinical, and RIM. This role also involves client engagement, process optimization, and enabling operational excellence within regulated Agile environments.

Your key responsibilities

Lead validation activities for GxP and non GxP systems using a risk‑based approach aligned with GAMP 5 and SDLC principles.
Perform software classification, IT risk assessments, and define mitigation strategies.
Conduct gap assessments and remediation for legacy or non‑compliant systems.
Author and review core validation deliverables (URS, FRS, Validation Plans, IQ/OQ/PQ, Traceability Matrix, Final Reports).
Maintain audit‑ready documentation and ensure end‑to‑end da

📌 RC-REGULATORY COMPLIANCE-CSV-QA (Pune)
🏢 EY
📍 Pune