10+ years of experience in Veeva Vault Quality Docs/QMS.
10+ years of business analysis experience in Pharmaceutical/Life Sciences.
6+ years of experience with GxP, 21 CFR Part 11, and CSV compliance.
Proven stakeholder management experience in Quality Assurance and Regulatory Affairs.
Experience in designing document lifecycle workflows.
Veeva Vault Certification preferred.
Strong verbal and written communication skills.
Responsibilities
Drive end-to-end business analysis for Veeva Quality Docs and QMS projects.
Gather, validate, and document business and functional requirements.
Convert quality processes into user stories and functional specifications.
Plan and lead stakeholder workshops and interviews.
Align stakeholder groups on project scope and priorities while managing interests.
Collaborate with Veeva technical consultants to ensure accurate requirements delivery.
Support design of document lifecycle workflows and training record structures.
Ensure adherence to GxP, 21 CFR Part 11, and CSV compliance principles.
Benefits
Opportunity to work with cutting-edge Veeva technology in a regulated environment.
Engagement with multidisciplinary teams including QA, Compliance, and Regulatory Affairs.
Chance to influence and shape quality processes within an industry-leading organization.
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.
