Senior Business Analyst

Creative Solutions Services, LLC; Warren Township (NJ); On-site; USD 110,000 - 170,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Senior Business Analyst – Veeva Vault Quality to support Business & Technology Integration for Veeva Quality Docs/QMS in the Life Sciences domain. You will gather requirements, create user stories, design workflows, and liaise between Business and IT in a GxP-regulated environment.

Responsibilities include end-to-end analysis of Veeva Quality Docs/QMS projects, documenting requirements, converting processes into stories and specs, leading workshops with

Qualifications

• 10+ years of experience with Veeva Vault Quality Docs/QMS.
• 10+ years of Business Analysis in Pharma/Life Sciences.
• 6+ years with GxP, 21 CFR Part 11, and CSV.
• 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

Veeva Vault QMS

Business Analysis

GxP compliance

21 CFR Part 11

Regulatory Affairs coordination

Education

Bachelor's degree in Life Sciences or related field

Veeva Vault Certification

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.