RC-REGULATORY COMPLIANCE-CSV-QA -Manager

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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 opportunity 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 data integrity throughout the system lifecycle. Act as SME during internal audits and regulatory inspections, driving CAPA implementation. Support transformation initiatives involving enterprise systems (SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, RIMS). Lead data migration, integration, and system connectivity activities across validated platforms. Evaluate and validate system changes through structured impact assessments. Manage periodic reviews, revalidation, and system retirement activities. Facilitate all Agile/Scrum ceremonies (daily stand‑ups, sprint planning, refinement, reviews, retrospectives). Coach and mentor teams on Agile principles, Scrum best practices, and self‑organization. Support Product Owners with backlog grooming, prioritization, and defining acceptance criteria. Remove impediments and coordinate resolution across cross‑functional business and technical teams. Maintain Agile metrics (velocity, burndown charts, RAID logs, dashboards) to ensure delivery transparency. Foster a collaborative, trust‑based team culture that encourages open communication and continuous improvement. Ensure sprint deliverables (configs, test evidence, requirements) comply with validation and documentation standards. Align business stakeholders, technical teams, and validation leads on sprint goals and regulatory expectations. Identify process improvements and embed actionable items into sprint cycles. Troubleshoot system or application issues and coordinate with SMEs for resolution. Develop validation and Agile delivery strategies aligned with client objectives and regulatory requirements. Prepare project updates, leadership presentations, and status communications. Mentor, train, and upskill team members across validation, compliance, and Agile practices. Maintain strong client focus, build trusted relationships, and support business development