Veeva Vault Solution Architect – Clinical, Regulatory, Quality Systems
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Job Description
Veeva Vault Solution Architect providing technical leadership on Veeva applications for clinical and regulatory operations. Collaborating with teams to ensure compliance and implement scalable solutions.
Responsibilities:
- Serve as the technical subject matter expert for Veeva Clinical, RIM, and Quality applications.
- Define solution architecture, configuration standards, integration patterns, and technical governance for the Veeva Vault platform.
- Gather and analyze business, technical, data, security, and regulatory requirements and translate them into scalable solution designs.
- Lead requirements workshops, architecture sessions, design reviews, and technical decision-making with business and technology stakeholders.
- Design and oversee integrations between Veeva Vault and clinical, regulatory, quality, enterprise, and data platforms.
- Provide technical oversight for system implementations, enhancements, upgrades, releases, and application lifecycle activities.
- Partner with development and implementation teams to review technical designs, APIs, data mappings, migration approaches, and custom components.
- Recommend the effective use of standard Veeva capabilities to minimize unnecessary customization and improve maintainability.
- Support Computer Software Assurance and Computer System Validation activities, including risk assessments, validation planning, testing, traceability, and change control.
- Ensure solutions support applicable requirements, including GxP, 21 CFR Part 11, EU Annex 11, data integrity, security, privacy, records retention, and audit trail requirements.
Requirements:
- 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.
- Strong understanding of Veeva Vault architecture, configuration, security, workflows, object models, reporting, APIs, and integration capabilities.
- Current Veeva certification or demonstrated implementation experience in relevant Veeva applications is strongly preferred.
- Knowledge of GxP, FDA regulations, 21 CFR Part 11, EU Annex 11, and applicable data integrity requirements.
- Ability to manage multiple priorities and work effectively across business, technical, and vendor teams in a fast-paced environment.
Benefits:
- None specified
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