Senior Business Analyst

Karwell Technologies

Warren, NJ

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JOB DETAILS

SKILLS

Biology, Biotech and Pharmaceutical, Business Analysis, Business Support, Code of Federal Regulations, Communication Skills, Design Document, Functional Testing, GxP, Insurance Regulations, Presentation/Verbal Skills, Quality Assurance, Regulations, Regulatory Compliance, Requirements Management, Use Cases, Writing Skills

LOCATION

Warren, NJ

POSTED

2 days ago

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.

Senior Business Analyst

Karwell Technologies

Warren, NJ

About the Company

Karwell Technologies

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