Business Analyst Veeva Vault

Job Title:

Business Analyst with Veeva Vault

Location:

West Point, PA (Hybrid 2 to 3 days onsite a week)

Hire type:
Contract on W2

• Deep expertise in Veeva Vault QMS, including end-to-end process design, configuration support, and deployment for core QMS processes.
• QMS business domain SME with strong knowledge of end-to-end Deviations and CAPA management, and GMP/GCP/GLP Audits & Inspections processes.
• Proven experience as Lead Business Analyst on multiple large-scale QMS implementations within the life sciences / regulated lifecycle industry.
• Strong capability in process standardization, simplification, and transformation, including defining global/to-be processes and harmonizing site or functional variations.
• Demonstrated ability to lead and facilitate cross-functional business SME groups, driving alignment on requirements, processes, and design decisions.
• Expertise in eliciting, analyzing, and documenting business requirements, user stories, use cases, and acceptance criteria for complex QMS solutions.
• Experience working in Agile delivery models, collaborating closely with product owners, technical teams, and QA/validation to refine backlogs and ensure high-quality deliverables.
• Strong understanding of GxP, regulatory, and validation requirements related to electronic QMS solutions, including impact on requirements, testing, and documentation.
• Excellent communication and stakeholder management skills, able to translate business needs into clear, actionable specifications and facilitate workshops and decision-making sessions.

• Strong understanding of GxP, regulatory, and validation requirements related to electronic QMS solutions, including impact on requirements, testing, and documentation.
• Excellent communication and stakeholder management skills, able to translate business needs into clear, actionable specifications and facilitate workshops and decision-making sessions.
• Proficiency with JIRA and related tools for managing requirements, user stories, traceability, and status, as well as preparing clear business-facing and leadership updates.
• Strong technical writing experience for Veeva Vault QMS, including creation and maintenance of process, system, and user documentation.
• Subject matter expertise in QMS processes, specifically Deviations and CAPA, with the ability to accurately translate SME input into clear, structured documentation.
• Experience developing QMS documentation and supporting SDLC activities (requirements, functional specifications, configuration documents, test scripts, release notes, user guides).
• Proficiency in business process mapping and modeling (e.g., workflows, swimlanes, SIPOC), and converting process maps into readable, role-based procedures and work instructions.
• Skilled in content creation for a regulated environment, including SOPs, Work Instructions, Job Aids, Quick Reference Guides, training materials, and FAQs.
• Strong familiarity with GxP, quality, and regulatory requirements to ensure documentation is complete, compliant, and audit-ready.
• Experience working with enterprise content management tools and standards (e.g., SharePoint, Confluence, document control systems) for authoring, version control, review/approval, and publication.
• Ability to collaborate closely with business SMEs, product owners, and technical teams to collect inputs, clarify requirements, and ensure documentation accurately reflects as-is and to-be processes.