Business Analyst with Veeva Vault - Lansdale, PA
1 day ago
Job description
Position: Business Analyst with Veeva Vault
Location: West Point PA (Hybrid 2 to 3 days onsite a week)
Must Have Experience
- 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
Job Description
- 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.
- Excellent written communication skills with a focus on clarity, consistency, and usability for global, cross-functional audiences.
- Ability to manage multiple documentation deliverables across workstreams, adhering to project timelines, templates, and documentation governance standards.
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