Veeva Vault EQMS Specialist

Responsibilities:

• Lead or support end-to-end implementation of Veeva Vault Quality Suite, including requirements gathering, configuration, testing, validation, and go-live activities.
• Translate business needs into functional specifications and system design within Veeva Vault.
• Configure and optimize workflows, document types, metadata, training assignments, quality processes, and user roles.
• Conduct detailed process mapping of current-state and future-state EQMS processes (e.g., Document Management, Change Control, Deviations, CAPA, Complaints, Training).
• Facilitate workshops with cross-functional stakeholders to define requirements and align system capabilities with business objectives.
• Identify opportunities for process improvements and automation within Veeva.
• Support or lead system validation activities including user requirements (URS), functional specifications, IQ/OQ/PQ, and change control in compliance with GxP and 21 CFR Part 11.
• Ensure adherence to internal quality standards, regulatory expectations, and IT/CSV methodologies.
• Testing & Deployment
• Develop and execute test scripts, manage defects, and facilitate UAT sessions.
• Support go-live planning, cutover activities, and hypercare.
• Maintain updates to Veeva releases, including impact assessments and regression testing.
• Training & Support
• Develop user training materials and deliver hands-on training for business end users.
• Provide ongoing support, troubleshoot issues, and manage enhancement requests.
• Serve as a subject matter expert (SME) for Veeva Vault within the Quality organization.

Requirements:

• 3+ years of experience as a Business Analyst in Life Sciences Quality (Pharma, Biotech, or Medical Devices).
• Hands-on experience with full Veeva Vault implementations, ideally within the Vault Quality Suite (QualityDocs, QMS, Training).
• Strong working knowledge of GxP, 21 CFR Part 11, Annex 11, and core quality system processes.
• Experience with computer system validation (CSV) and creation of validation documentation.
• Excellent communication skills with the ability to translate technical concepts for non-technical audiences.
• Strong analytical, problem‑solving, and stakeholder management capabilities.
• Must be able to work on site Monday to Friday.

Preferred Qualifications:

• Veeva Vault Administrator or Vault Quality certification.
• Experience working with global teams and regulated environments.
• Familiarity with integration tools, APIs, and downstream/upstream system interfaces.
• Experience in managing enhancements post-implementation and supporting continuous improvement.