Senior Business Analyst - Regulatory Compliance and Digital Quality Management Systems

Job description

RC-REGULATORY COMPLIANCE-Digital QMS - BA-Senior At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. EY -- GDS Consulting -- Enterprise Risk (ER) -- Regulatory Compliance Senior- QMS Business Analyst (Veeva Vault) At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. 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 senior 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 Senior Business Analyst -- Veeva Vault QMS with proven consulting experience to partner with business and IT teams in designing, implementing, and optimizing Veeva Vault Quality Management Systems (QMS) in regulated (GxP) environments. . You will drive discovery and requirements-to-delivery traceability, shape future-state workflows, support validation and audit readiness (CSV/CSA), and define data migration and integrity approaches for Veeva-enabled quality solutions across the pharmaceutical lifecycle. Role Overview In this client-facing Business Analyst role, you will lead requirements and process design activities across Veeva Vault QMS programs. You will facilitate workshops, document functional requirements and acceptance criteria, and collaborate with QA/Validation and technical teams to ensure audit-ready delivery aligned with global regulatory standards. You will contribute to successful implementation, integration, and adoption of Veeva Vault Quality solutions in GxP-regulated environments Your key responsibilities Lead end-to-end requirements discovery (workshops/interviews) to convert business objectives into epics/user stories, acceptance criteria, and functional specifications. Define As Is/To Be processes, workflow designs, and business rules; maintain requirements baseline, decision log, and end-to-end traceability (requirements → config/design → testing → validation evidence). Own and prioritize the backlog in Jira/ADO, balancing enhancements, defects, compliance needs, and technical debt in an Agile GxP hybrid delivery model. Act as the primary liaison across Business, QA/Validation, IT, and Vendors to align scope, releases, and measurable outcomes. Provide configuration-informed functional leadership for Veeva Vault solutions (objects, lifecycles, workflows, security/roles, document types, metadata). Provide functional leadership across Veeva Vault QMS modules, including: Deviations, CAPA, Change Control, Audit Management, Complaints, Supplier Quality, etc. Perform gap analysis (OOTB vs configuration vs integration) and recommend scalable, compliant solutions; partner with technical teams to translate requirements into Vault configuration and integration designs. Define and support data migration strategy: profiling, field mapping, transformation rules, cleansing, reconciliation, and validation of migrated data; ensure integrity across legacy ↔ Vault and Vault ↔ enterprise flows. Ensure compliance with GxP, 21 CFR Part 11, Annex 11 (where applicable), and GAMP 5; apply a CSV-to-CSA, risk-based mindset. Author/review/coordinate validation deliverables including URS/FRS, risk/impact assessments, Traceability Matrix, and testing/validation evidence (IQ/OQ/PQ where required). Lead UAT planning and execution (scenarios, test data, defect triage, retesting, sign-off); manage test/defects via qTest/ALM/Jira and produce dashboards for progress, coverage, and quality metrics. Manage tri-annual Veeva release impacts (assessment, adoption planning, regression/UAT scope, compliance impacts); support change control, deviations, and CAPA linkage (as applicable). Mentor junior BAs and contribute to templates/accelerators and continuous improvement; support business development activities as needed (RFP inputs, solution narratives, estimates). Qualifications: Bachelor's degree in a relevant discipline such as Computer Science, Information Systems, Life Sciences, Engineering, or equivalent practical experience. 5--9 years of progressive experience in Business Analysis roles supporting enterprise technology delivery within regulated and compliance-driven environments. Demonstrated experience working with Veeva Vault applications, with strong functional understanding of associated business processes and end-to-end workflows. Proven ability to operate effectively in Agile/Scrum delivery models, contributing to iterative planning, continuous improvement, and value-based delivery. Strong working knowledge of regulated system expectations, including GxP compliance and validation approaches (CSV/CSA), with practical awareness of 21 CFR Part 11 requirements. Exceptional analytical thinking and structured problem-solving capabilities, with strong executive-ready communication, stakeholder engagement, and high-quality documentation skills. Must-Have Skills \& Attributes Core Veeva Regulated Delivery Hands-on BA experience on Veeva Vault QMS with strong understanding of configuration concepts: objects, lifecycles, workflows, security roles, document types, metadata. Deep knowledge of QMS processes (Deviation, CAPA, Change Control, Audit, Complaints). Deep compliance fluency: GxP, 21 CFR Part 11, GAMP 5; strong validated-state impact thinking and practical experience with CSV/CSA