Veeva QMS Technical Functional Business Analyst

Role: Veeva QMS Technical Functional Business Analyst

Location: Princeton, NJ (Hybrid, 3 onsite role per week)

Hire Type: Contract

Job Description-

Job Summary-

We are looking for an experienced Veeva QMS Technical Functional Business Analyst to support the implementation, configuration, enhancement, and maintenance of Veeva Vault Quality Management System (QMS) solutions.

The candidate will work closely with business stakeholders, Quality Assurance (QA), Quality Control (QC), Manufacturing, Regulatory Affairs, IT, and technical teams to understand business requirements and translate them into functional and technical specifications.

Key Responsibilities

1. Business Analysis

• Gather, analyze, and document business requirements from stakeholders.
• Conduct requirement-gathering sessions and business process workshops.
• Prepare BRD, FRD, FRS, and Functional Design Documents.
• Perform gap analysis and impact assessment.
• Create user stories, acceptance criteria, and process flow diagrams.
• Translate business requirements into Veeva Vault QMS solutions.

2. Veeva QMS Functional Knowledge

• Work on Veeva Vault QMS implementation and enhancements.
• Understand and support the following quality processes:
• Deviation Management
• CAPA Management
• Change Control Management
• Audit Management
• Complaint Management
• Quality Events
• Document Control
• Training Management
• Understand end-to-end quality management workflows.
• Support business process optimization and system improvements.

3. Technical Functional Knowledge

• Understand Veeva Vault architecture and configuration.
• Work with Vault objects, fields, relationships, and layouts.
• Understand lifecycle configuration and workflow administration.
• Support role-based access control and security configuration.
• Understand document types, document lifecycles, and metadata.
• Coordinate with technical teams for integrations and data migration.
• Support system configuration and troubleshooting.

4. Testing and Validation

• Prepare test scenarios, test cases, and test scripts.
• Coordinate System Integration Testing (SIT) and User Acceptance Testing (UAT).
• Perform functional testing and regression testing.
• Manage defects and coordinate resolutions.
• Support GxP validation activities.
• Prepare and maintain Requirements Traceability Matrix (RTM).