Techno-Functional Veeva Vault Quality Management (QMS) consultant/GxP quality operations

Client: Pharma / Lifescience

Location: Onsite Princeton NJPosition Type- Contract

Rate: USD $/hr on W2Job Description/ Responsibilities· 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 Quality Docs, 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? xhyhwjd · Are you working on a new implementation or migrating from a legacy system? Regards, Sayyad Ashraf