RC - REGULATORY COMPLIANCE - QMS - BA - Veeva - Manager

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EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Manager - Business Analyst (Veeva Vault Suite – Life Sciences)   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 an experienced Manager – Business Analyst with strong consulting skills and deep expertise in Veeva Vault applications to lead IT implementation projects in regulated GxP environments. This role combines delivery leadership, stakeholder engagement, and business development support to drive successful outcomes across Veeva-based solutions for the pharmaceutical lifecycle.     Role Overview   As a Manager, you will own client relationships, lead teams of analysts, and ensure high-quality delivery of Veeva Vault projects. You will guide requirements definition, process optimization, validation planning, and data migration/integration strategies, while also supporting senior leadership in client pursuits and RFP responses. This role demands strong consulting acumen, ability to manage complex programs, and a focus on operational excellence.     Your key responsibilities

Lead end-to-end delivery of Business Analysis workstreams for Veeva Vault Quality Suite, Safety Suite, RIM Suite, Clinical Suite Drive requirements management, including workshops for as-is/to-be analysis, workflow design, and data mapping between legacy and Veeva systems. Oversee data migration and system integration planning, ensuring alignment with business processes and compliance requirements. Provide strategic guidance on validation planning, including authoring and reviewing documentation (Validation Plan, URS, FRS, IQ/OQ/PQ, Validation Report). Manage requirement traceability and testing governance using tools like JIRA, Confluence, qTest, and ALM. Develop dashboards and reporting frameworks for project performance, risks, and compliance tracking. Act as a trusted advisor to clients, ensuring stakeholder alignment and managing expectations at senior leadership levels. Mentor and coach junior team members, fostering a culture of collaboration and continuous improvement. Support business development initiatives, including assisting senior leadership with client pursuits, drafting RFP responses, and delivering impactful presentations. Contribute to thought leadership and internal capability-building initiatives within the Regulatory Compliance practice.

Bachelor’s degree in computer science, Information Technology, Life Sciences or a related field, advanced degree preferred. 8-12 years of experience as a Business Analyst in IT projects within regulated environments, with at least 3–5 years in a leadership capacity. Strong understanding of QMS/ Safety/ Regulatory/ Clinical processes and how these are structured into workflows within Veeva Vault applications (Quality Suite/ Safety Suite/ RIM Suite/ Clinical) Proven experience managing large-scale Veeva Vault implementation projects. Strong understanding of SDLC, Agile methodologies, and GxP compliance frameworks.