QualityDocs / PDOC Business Analyst (Veeva QualityDocs)

Position Title: QualityDocs / PDOC Business Analyst (Veeva QualityDocs)

Experience Level: 3 Expert

Overview

We are seeking an experienced Business Analyst with strong expertise in Veeva Vault QualityDocs (DMS) to support implementation and enhancement initiatives in a regulated GxP environment. The role requires deep knowledge of Agile delivery, SDLC, and Computer System Validation (CSV), along with hands-on experience in Veeva Vault administration and configuration.

Key Responsibilities

• Act as a Business Analyst for Veeva Vault QualityDocs / PDOC implementations and enhancements.
• Gather, analyze, and translate business requirements into:
• User Stories
• Functional Specifications (as applicable)
• Validation documentation (Test Scripts, Traceability, etc.)
• Support Veeva Vault QualityDocs configuration and administration, including:
• User and role management
• Metadata configuration
• Document lifecycles and workflows
• Collaborate with QA, Business, and IT teams to support validation activities and ensure compliance with CSV, GxP, and regulatory standards.
• Participate in sprint planning, backlog grooming, and Agile ceremonies.
• Support ongoing system enhancements, change management, and continuous delivery.
• Ensure documentation and system processes meet audit and compliance requirements.

Required Qualifications

• 5+ years of experience as a Business Analyst in a regulated Life Sciences / Pharma environment.
• Strong hands-on experience with Veeva Vault, specifically QualityDocs.
• Solid understanding of:
• Agile methodologies
• Software Development Lifecycle (SDLC)
• Computer System Validation (CSV) and GxP regulations
• Experience creating validation deliverables (e.g., Test Scripts, RTM).
• Excellent communication, stakeholder management, and documentation skills.

Preferred Skills

• Hands-on experience with Veeva Vault Admin tasks
• Experience working in cross-functional Agile teams
• Strong attention to compliance, detail, and audit readiness