Senior Business Analyst Veeva Vault Quality

Senior Business Analyst - Veeva Vault Quality

.Work Setup: Hybrid model on-site in Warren, NJ.
Reason for Opening: Business & Technology Integration support for Life Sciences Veeva Quality Docs/QMS implementation.
Deliverables/Scope: Requirements gathering, user story creation, workflow design, CSV alignment, and liaison between IT and Business teams.
Interview Process: Standard client interview sequence focusing on Veeva technical depth and pharma quality processes.
Special Requirements: No visa restrictions. Suppliers need to be Workday Partners. Consultants must hold active Veeva certifications. Travel and expenses will be paid by the client if required. High probability of extension.

TOP HARD SKILLS
Veeva Vault Quality Docs / QMS 10+ years of experience
Pharmaceutical / Life Sciences Domain Experience 10+ years of experience
GxP / 21 CFR Part 11 / CSV Principles 6+ years of experience

Active Veeva Vault Certification

NICE-TO-HAVES
Experience managing CAPA, Change Control, and Deviations workflows
Exemplary senior-level communication and workshop facilitation skills

DISQUALIFIERS
Lack of Veeva Vault Quality experience or missing required active certifications
No background in Pharmaceutical/Life Sciences computer system validation (CSV)
Inability to work on-site in Warren, NJ under the required hybrid schedule

POSITION OVERVIEW

• 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.

DAY-TO-DAY RESPONSIBILITIES

• 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.

TOP 3 REQUIRED SKILLS

• 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

ADDITIONAL DESIRED SKILLS

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

CANDIDATE PROFILE

• 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.

Job Responsibilities

• 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 lifecycles and training record structures. Participate in project governance to ensure solutions meet strict GxP, 21 CFR Part 11, and computer system validation standards.