Techno-Functional Veeva Vault Quality Management (QMS) consultant/GxP quality operations
Techno-Functional Veeva Vault Quality Management (QMS) consultant/GxP quality operations
Posted 2 days ago
SENIORITY
Manager
About the role
- A Techno-Functional Veeva Quality Management (QMS) consultant or specialist bridges the gap between life sciences business processes (Quality Assurance/Quality Control) and the technical configuration of the Veeva Vault QMS platform. Core Functional Responsibilities
- Process Standardization: Translate global GxP quality operations into standardized system workflows. This covers:
- Deviations and Non-Conformances
- Corrective and Preventive Actions (CAPA)
- Change Control
- Audits (Internal and External/Supplier) Complaints and Lab Investigations
- Quality Risk Management (QRM)
- Requirements & Documentation: Gather business requirements, conduct fit-gap analyses, and author functional specifications (FS), user stories, User Requirements Specifications (URS), and Design Specifications (DS).
- Validation & Testing: Prepare and execute validation deliverables, including Installation Qualification (IQ), Operational Qualification (OQ), Traceability Matrices, and User Acceptance Testing (UAT).
- Change Management & Training: Lead user adoption, training rollout, release planning, and impact assessments for system upgrades. Core Technical Responsibilities
- Vault Platform Configuration: Configure object models, lifecycles, states, user roles, security settings, and automated workflows within Veeva Vault.
- Integrations: Design and support data flows between Veeva Vault QMS and connected enterprise ecosystems—such as Veeva QualityDocs, ERP, LIMS, RIM, and Safety modules.
- Data Migration & Mapping: Oversee data mapping, cleansing, and migration from legacy QMS platforms into Veeva Vault.
- Compliance & Audit Trails: Ensure system design aligns with regulatory standards like 21 CFR Part 11 and EU Annex 11, including configuring electronic signatures and required "reasons for change".
- Reporting & Analytics: Build custom reports, dashboards, and object metrics to give quality teams real-time visibility into metrics like CAPA cycle times and deviation trends. If you are preparing for a role or project, let me know:
- Are you focusing more on the functional QMS processes (like CAPA/Change Control) or the technical Vault configuration?
- Are you working on a new implementation or migrating from a legacy system? Regards, Sayyad Ashraf
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