Job Title: Veeva Vault Solution Architect Location: US Remote (Remote in EST Hours) Key ID: QUA105

Role Overview: This role is responsible for developing and maintaining solution architecture, system administration, security, and procedures across the Veeva Vault Platform. The individual will work closely with the client Quality Veeva team, Business Analysts, and the Validation team to ensure the Veeva Vault implementation aligns with the business and regulatory requirements.

Key Responsibilities:

Support all assigned development activities for the Veeva Vault implementation program under the leadership of the client Quality Veeva team.

Coordinate with Business Analysts to outline the business requirements and ensure IT security and Data Integrity requirements are properly defined for the solution.

Work with the Validation team to prepare the Regulatory Applicability Assessment and Regulatory Risk Assessment documents.

Document specifications and user stories.

Conduct technical feasibility analysis of business requirements.

Document system design or configuration specifications.

Perform Veeva environment management.

Develop custom solutions and integrations to automate workflows, enhance system capabilities, and ensure seamless integration with third-party applications.

Required Skills and Experience:

Configuration and Customization: Experience in setting up and customizing Veeva Vault applications to meet client-specific requirements.

Veeva Vault Quality: Strong emphasis on QMS experience; documented certification and experience in a GxP environment is highly preferred.

Custom Solutions and Integrations: Experience developing custom solutions and integrations to automate workflows, enhance system capabilities, and ensure seamless integration with third-party applications.

Development and Implementation: Experience building and deploying solutions using Veeva Vault functionalities, including workflows, metadata structures, and security settings.

Integration Experience: Developing and managing integrations between Veeva Vault and other enterprise systems (e.g., SAP, Salesforce) using technologies like APIs, SOAP, and REST.

Technical Proficiency: Proficiency in relevant technologies like XML, SQL, APIs, and programming languages like Java and JavaScript.

Cloud-Based Solutions: Proven experience in the development of cloud-based solutions.

SDLC and GxP Validated Systems: Familiarity with SDLC and the delivery of GxP validated systems.

Veeva QMS Certification: Highly preferred.

This is a remote position.