Senior Business Analyst

Job Summary:

• We are seeking a Senior Business Analyst – Veeva Vault Quality to support Business & Technology Integration for Veeva Quality Docs/QMS implementation within the Life Sciences domain.
• The role is responsible for gathering business requirements, creating user stories, designing workflows, ensuring CSV alignment, and serving as the liaison between Business and IT teams in a GxP-regulated environment.

Roles & Responsibilities:

• Drive end-to-end business analysis across Veeva Quality Docs and QMS implementation and enhancement projects.
• Gather, document, and validate business and functional requirements for Veeva Quality Docs and QMS modules.
• Convert quality processes into user stories, use cases, and functional specifications.
• Plan and lead workshops and interviews with stakeholders across Quality Assurance, Regulatory Affairs, and Compliance.
• Align stakeholder groups on project scope and priorities while managing competing interests.
• Partner with Veeva technical consultants and configuration teams to ensure accurate delivery of requirements.
• Support the design of document lifecycle workflows and training record structures within Quality Docs.
• Ensure alignment with GxP, 21 CFR Part 11, and CSV compliance principles.

Education & Experience:

• 10+ years of experience with Veeva Vault Quality Docs/QMS.
• 10+ years of Business Analysis experience within the Pharmaceutical/Life Sciences industry.
• 6+ years of experience with GxP, 21 CFR Part 11, and CSV compliance.
• Experience with stakeholder management across QA and Regulatory Affairs.
• Experience in document lifecycle workflow design.
• Veeva Vault Certification is preferred.
• Strong written and verbal communication skills.