Veeva Vault Quality Systems Analyst:
The job description includes enabling, configuring, and optimizing Veeva's Quality Suite applications (QMS, QualityDees, Batch Release) to support end-to-end GxP quality processes. The role blends business process design, compliance, and cross-functional collaboration. The position exists to design, implement, and continuously improve digital quality systems using Veeva Vault. It ensures that quality and compliance processes are scalable, audit-ready, and aligned with global regulatory expectations.
Key Responsibilities:
Configuration
• Configure and maintain Veeva Vault Quality applications (QualityRees, QMS, Batch Release).
• Manage user roles, permissions, lifecycle states, workflows, and metadata.
• Oversee release management, including regression testing and validation of new Vault features.
• Ensure system changes follow GxPvalidation requirements and internal change control.
Business Process Analysis & Optimization
Lead discovery workshops to map current vs. future state quality processes.
•Translate business needs into functional and technical requirements.
•Develop scalable workflows for deviations, CAPA, complaints, audits, change control, batch release, and document management.
•Drive continuous improvement initiatives across global quality teams.
Documentation & Compliance
• Create and maintain system documentation: URS, FRS, configuration specs, validation scripts, SOPs, and training materials.
• Partner with QA to maintain a validated state of the system.
Cross-Functional Collaboration
• Serve as the liaison between Quality, IT, Training, LIMS, Supply Chains, Manufacturing, and Regulatory teams.
• Coordinate with Veeva or implementation partners on enhancements and issue resolution. • Provide functional expertise across quality systems.