Join EY's Regulatory Compliance team as a Manager – Business Analyst, specializing in Veeva Vault applications. This role is crucial for leading IT implementation projects within regulated GxP environments. You will leverage deep consulting expertise and a strong understanding of Veeva Vault to drive successful outcomes for pharmaceutical clients.

This position offers the opportunity to shape client relationships, manage project teams, and ensure the delivery of high-quality solutions. You will play a key part in defining requirements, optimizing processes, and developing integration strategies, while also supporting business development efforts.

EY is dedicated to fostering an inclusive culture where your unique perspective is valued. Build a rewarding career with global scale, robust support, and cutting-edge technology to help you become your best self.

Lead the complete delivery of Business Analysis for Veeva Vault's Quality, Safety, RIM, and Clinical Suites. Drive requirements management through workshops for as-is/to-be analysis, workflow design, and data mapping. Oversee data migration and system integration planning, ensuring compliance and alignment with business processes.

Provide strategic guidance on validation planning, including authoring and reviewing essential documentation like Validation Plans, URS, FRS, IQ/OQ/PQ, and Validation Reports. Manage requirement traceability and testing governance using tools such as JIRA, Confluence, qTest, and ALM. Develop performance, risk, and compliance tracking dashboards.

Serve as a trusted advisor to clients, managing stakeholder expectations and ensuring alignment at senior leadership levels. Mentor junior team members to foster collaboration and continuous improvement. Support business development by assisting with client pursuits, RFP responses, and presentations. Contribute to thought leadership and internal capability building.

A Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related field is required, with an advanced degree being preferred. Possess 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.

Demonstrate a strong understanding of QMS, Safety, Regulatory, and Clinical processes, and their implementation within Veeva Vault applications (Quality, Safety, RIM, Clinical Suites). Proven experience managing large-scale Veeva Vault implementation projects is essential.

Solid grasp of SDLC, Agile methodologies, and GxP compliance frameworks. Expertise in CSV/CSA methodologies, validation planning, and audit readiness is critical. Exceptional communication, stakeholder management, and client engagement skills are necessary for this role.