Join EY's Regulatory Compliance team as a Senior Business Analyst specializing in Veeva Vault QMS. This client-facing role involves partnering with business and IT teams to design, implement, and optimize Veeva Vault Quality Management Systems within regulated GxP environments.

You will drive the full lifecycle of projects, from requirements gathering to delivery, shaping future workflows, supporting validation processes, and defining data migration strategies for Veeva-enabled quality solutions. Your expertise will be crucial in ensuring audit readiness and adherence to global regulatory standards across the pharmaceutical lifecycle.

Lead end-to-end requirements discovery through workshops and interviews, translating business objectives into detailed epics and user stories. Define As-Is/To-Be processes, workflow designs, and business rules, maintaining traceability from requirements to validation evidence. Own and prioritize the product backlog in Jira/ADO, managing enhancements, defects, and compliance needs within an Agile-GxP hybrid model. Serve as the primary liaison between Business, QA/Validation, IT, and Vendors to align scope, releases, and outcomes. Provide functional leadership for Veeva Vault configurations, including objects, lifecycles, workflows, and security. Drive gap analysis and recommend compliant solutions, collaborating with technical teams to translate requirements into Vault configurations and integration designs. Define and support data migration strategies, ensuring data integrity across legacy and enterprise systems. Ensure compliance with GxP, 21 CFR Part 11, and GAMP 5, applying a risk-based CSV/CSA mindset. Author and review validation deliverables, including URS/FRS, risk assessments, and testing evidence. Lead UAT planning and execution, managing test data, defect triage, and sign-off processes. Manage impacts of tri-annual Veeva releases and support change control processes. Mentor junior BAs, contribute to templates, and support business development activities as needed.

A Bachelor's degree in a relevant field like Computer Science, Information Systems, Life Sciences, or Engineering, or equivalent practical experience. Possess 5–9 years of progressive experience in Business Analysis roles, supporting enterprise technology delivery in regulated environments. Demonstrated hands-on experience with Veeva Vault applications and a strong understanding of associated business processes. Proven ability to thrive in Agile/Scrum delivery models, contributing to iterative planning and value-based delivery. Solid working knowledge of regulated system expectations, including GxP compliance and validation approaches (CSV/CSA), with awareness of 21 CFR Part 11 requirements. Exceptional analytical thinking, problem-solving skills, and strong executive-ready communication and stakeholder engagement abilities.