RC-REGULATORY COMPLIANCE-Digital QMS - BA-Senior

EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance Senior- QMS Business Analyst (Veeva Vault)

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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 approaches.
  • Advanced requirements engineering user stories/acceptance criteria, functional specs, traceability and governance within Agile GxP hybrid delivery.
• Tools & Execution
  • Proficiency with Jira/Confluence (or ADO), modeling tools (Visio/Lucid/Mural), and test/validation tools (qTest/ALM).
  • Proven UAT leadership: planning, execution, defect triage, stakeholder sign-off; ability to produce audit-ready evidence.
  • Strong dashboarding/reporting capability: executive-ready status on risks, issues, outcomes, and test quality.
• Data & Integration Competence
  • Data migration expertise: field mapping, transformation rules, reconciliation, and migrated data validation.
  •  Working knowledge of integrations and enterprise data flow; effective partnership with technical teams on interfaces (Vault ↔ other systems).
• Leadership & Communication
  • Strong stakeholder diplomacy and negotiation; ability to prioritize and push back constructively (no/not now”) while maintaining alignment.
  • Analytical problem-solving and root-cause mindset for workflow failures and data issues.
  • Excellent communication and documentation; strong client-facing presence.
• Certifications (Expected/Strongly Preferred for Senior)
  •  At least one: Veeva Vault Administrator Certification and/or Veeva White Belt.

Good-to-Have Skills & Attributes

• Technical/Platform Edge
  • Cross-suite / multi-vault understanding (Clinical ↔ Regulatory ↔ Quality dependencies and end-to-end data integrity).
  • High-level API fundamentals (REST) and integration ecosystem awareness (middleware, data lake/warehouse, MDM concepts).
  • Basic SQL and/or Power BI/Tableau experience to augment Vault reporting.
• Modern Quality & Delivery Methods
  • Strong CSA mindset and risk-based testing experience beyond scripted validation.
  •  Lean / Six Sigma exposure for process optimization (avoid digitizing broken processes).
  • Change management exposure/certification (e.g., Prosci) for large/global rollouts and adoption.
• Advanced BA/Leadership Attributes
  • Product Owner mentality: advocate for OOTB best practices, challenge non-value-add customizations, and manage technical debt.
  • Global rollout experience across regions/time zones; awareness of regulatory/process nuance.
  •  Training & adoption skills: lead enablement sessions, create training materials, drive sustained adoption.
  • Awareness of AI-enabled Veeva use cases (where permitted): tagging/classification, intelligent search, workflow automation.

What we look for

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

What working at EY offers

At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

• Support, coaching and feedback from some of the most engaging colleagues around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way that’s right for you