Senior Business Analyst - Veeva Vault Quality

Title:

Business Analyst

Location:

Warren, NJ (Hybrid)

• Drive end-to-end business analysis across Veeva Quality Docs and QMS implementation and enhancement projects within the Life Sciences domain. This role serves as the critical bridge between Quality and Compliance business stakeholders and the IT delivery team to ensure system configurations align with regulated quality processes. The ideal candidate brings deep pharmaceutical industry expertise and hands-on experience structuring functional requirements in a GxP-compliant environment.

• Gather, document, and validate business and functional requirements across Veeva Quality Docs and QMS modules. Convert complex quality processes into clear user stories, use cases, and functional specifications. Plan and lead workshops and interviews with senior stakeholders across Quality Assurance, Regulatory Affairs, and Compliance. Align stakeholder groups around agreed scope and priorities while proactively managing competing interests. Partner with Veeva technical consultants and configuration teams to ensure requirements are delivered accurately.
  
  Support the design of document lifecycle workflows and training record structures within Quality Docs.

• Veeva Vault Quality Docs & QMS – 10+ years Business Analysis in Pharmaceutical/Life Sciences Industry – 10+ years GxP, 21 CFR Part 11, and CSV Compliance Knowledge – 6+ years

• Veeva Vault Certification Strong written and verbal communication skills Stakeholder management across QA and Regulatory Affairs Document lifecycle workflow design

• A highly senior Life Sciences Business Analyst with a strong technology background and deep expertise in pharmaceutical Quality Assurance processes. The ideal candidate is a collaborative problem-solver who possesses active Veeva certifications and can comfortably facilitate technical workshops with executive quality stakeholders. They bring a polished, compliance-minded approach to translating complex regulations into actionable software requirement specifications.

• Translate complex pharmaceutical quality processes into clear functional specifications, user stories, and use cases. Facilitate workshops with senior leadership across Quality Assurance, Regulatory Affairs, and Compliance to define system scope. Collaborate closely with Veeva technical consultants to ensure accurate design of document life cycles and training record structures. Participate in project governance to ensure solutions meet strict GxP, 21 CFR Part 11, and computer system validation standards.