10+ years of experience with Veeva Vault Quality Docs/QMS
10+ years in Business Analysis within the Pharmaceutical/Life Sciences sector
6+ years working with GxP, 21 CFR Part 11, and CSV compliance
Proven track record in stakeholder management across QA and Regulatory Affairs
Background in document lifecycle workflow design
Preferred Veeva Vault Certification
Strong written and verbal communication skills
Responsibilities
Drive end-to-end business analysis for Veeva Quality Docs and QMS projects
Gather, document, and validate business and functional requirements
Convert quality processes into user stories and use cases
Plan and lead stakeholder workshops and interviews
Align stakeholder groups on project scope and prioritize competing interests
Partner with technical consultants to ensure requirement delivery
Support the design of document lifecycle workflows and training record structures
Ensure compliance with GxP and CSV principles
Benefits
Collaborative and dynamic work environment
Opportunities for professional development
Engagement in exciting projects within Life Sciences
Exposure to cutting-edge technology in quality management
Potential for flexible work arrangements
Full Job Description
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.
lign 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.
