Senior Business Analyst

Katalyst CRO; New Jersey; On-site; USD 140,000 - 180,000; Full time

Job summary

Katalyst CRO seeks a Senior Business Analyst focusing on Veeva Vault Quality Docs/QMS to drive business and technology integration in a GxP-regulated Life Sciences environment. You will translate regulatory processes into user stories, validate requirements, and collaborate with QA, Regulatory Affairs, and Compliance teams.

The role emphasizes CSV compliance, 21 CFR Part 11 alignment, and end-to-end workflow design, requiring 10+ years in Veeva Vault and business analysis, plus strong

Qualifications

• 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.
• Experience in document lifecycle workflow design.
• Veeva Vault Certification is preferred.
• Strong written and verbal communication skills.

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.
• Align 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.

Skills

Veeva Vault Quality Docs

Business Analysis

Stakeholder Management

Documentation Design

Tools

Veeva Vault

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.
• Align 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.
• Experience in document lifecycle workflow design.
• Veeva Vault Certification is preferred.
• Strong written and verbal communication skills.