Veeva Vault Solution Architect – Clinical, Regulatory, Quality Systems (Contractor)
Remote
Job Summary
Lead technical governance for Veeva Vault implementations across Clinical, Regulatory, and Quality operations by defining architecture, configuration standards, and integration patterns. Translate business and regulatory requirements into scalable designs while managing workshops, design reviews, and technical decision-making with stakeholders. Oversee integrations, system enhancements, upgrades, and data migrations, ensuring compliance with GxP, 21 CFR Part 11, and data integrity standards. Partner with development teams to review APIs, data mappings, and custom components, recommending standard capabilities to optimize maintainability. Support Computer System Validation activities, release management, and vendor oversight while documenting operational procedures and assessing product roadmaps. This 6–12-month 1099 contract requires a 5-year Veeva Vault expert with GxP knowledge and up to 10% travel.
Required Qualifications
- Bachelor's degree in Information Technology, Computer Science, Engineering, Life Sciences, or a related field
- At least 5 years of experience implementing, architecting, or supporting Veeva Vault solutions in the pharmaceutical, biotechnology, medical device, or life sciences industry
- Demonstrated experience with one or more of the following: Veeva Vault CTMS, Veeva Vault eTMF, Veeva RIM Submissions, Veeva RIM Submissions Archive, Veeva RIM Publishing, Veeva Vault QualityDocs, Veeva Vault QMS, Veeva Vault Training, Veeva LearnGxP
- Strong understanding of Veeva Vault architecture, configuration, security, workflows, object models, reporting, APIs, and integration capabilities
- Experience designing integrations, interfaces, and data migrations involving Veeva Vault and other regulated enterprise systems
- Working knowledge of software development practices, system development lifecycle methodologies, and release management
- Experience with Computer Software Assurance, Computer System Validation, and regulated system documentation
- Knowledge of GxP, FDA regulations, 21 CFR Part 11, EU Annex 11, and applicable data integrity requirements
- Ability to travel up to 10%, as needed
Desired Qualifications
- Current Veeva certification or demonstrated implementation experience in relevant Veeva applications is strongly preferred
- Strong analytical, technical documentation, communication, and stakeholder management skills
- Ability to manage multiple priorities and work effectively across business, technical, and vendor teams in a fast-paced environment
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