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 initiatives.
- Stay abreast of emerging industry trends, regulatory changes, and technology advancements relevant to Life Sciences.

Qualifications:

- Bachelor s or Master s degree in Life Sciences, Biotechnology, Computer Science, Engineering, or a related technical field.
- 8-12 years of experience in Computer System Validation (CSV), GxP system implementation, or regulated IT delivery within the pharmaceutical/life sciences industry.
- Certified Scrum Master (CSM), SAFe Scrum Master, or equivalent Agile certification.




- Solid understanding of GxP regulations, GAMP 5, 21 CFR Part 11, Annex 11, and data integrity principles.
- Hands on experience with regulated platforms such as Veeva Vault, SAP, LIMS, MES, ELN, Documentum, TrackWise, or ValGenesis.
- Proven experience working in Agile/Scrum environments and facilitating Scrum ceremonies.

Must-Have Skills & Attributes

- Strong knowledge of GxP regulations (FDA 21 CFR Part 11, EU Annex 11) and data integrity principles.
- Hands on understanding of GAMP 5 methodology and the full system development life cycle (SDLC).
- Proficiency in CSV documentation including URS, FRS, IQ/OQ/PQ, Traceability Matrix, and Validation Plans.
- Experience in performing risk assessments, software classification, and impact assessments for IT/validated systems.
- Ability to conduct gap analysis, remediation planning, and lifecycle management for legacy and regulated systems.
- Audit readiness expertise with experience supporting regulatory inspections and managing CAPA responses.
- Hands on experience with regulated platforms such as Veeva Vault, SAP, LIMS, ELN, MES, Documentum, TrackWise, ValGenesis, Argus, and RIMS.
- Experienced in Agile/Scrum environments with the ability to facilitate ceremonies, coach teams, and drive continuous improvement.
- Strong understanding of Agile metrics, backlog management, sprint execution, and cross functional collaboration.
- Ability to collaborate effectively with QA, IT, Manufacturing, Labs, business stakeholders, and Product Owners.
- Experience in client facing roles, managing expectations, requirements, and delivery outcomes.
- Excellent written and verbal communication skills, with strong documentation and presentation capabilities.
- Experience in IT project management, validation planning, and coordinating deliverables across teams.
- Ability to troubleshoot system/application issues and coordinate resolution with SMEs.
- Familiarity with change control, deviation management, CAPA workflows.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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