Veeva Vault RegulatoryOne Business Analyst
Asterism IT Solutions
Dice Job Match Score™
🛠️ Calibrating flux capacitors...
Job Details
Skills
- Microsoft Visio
- JIRA
- Management
- Microsoft Azure
- Corrective And Preventive Action
- Documentation
- Continuous Improvement
- DevOps
- Computerized System Validation
- Conflict Resolution
- Business Analysis
- Change Control
- Product Ownership
- Quality Management
- Product Lifecycle Management
- QMS
- Plant Lifecycle Management
- Process Flow
- Microsoft SharePoint
- Problem Solving
- Communication
- Software Development Methodology
- Requirements Elicitation
- Microsoft Power BI
- Roadmaps
- Agile
- Analytical Skill
- Auditing
- User Stories
- Stakeholder Management
- Testing
- System Integration Testing
- Acceptance Testing
- ServiceNow
- Veeva
- GxP
Summary
We are seeking a Technical Business Analyst to lead the strategy, roadmap, and delivery of digital solutions supporting Product Lifecycle Management (PLM), Quality Management Systems (QMS), and Regulatory processes across global R&D. This role combines product ownership with business analysis, partnering with stakeholders and technical teams to deliver compliant, scalable, and user-focused solutions.
Responsibilities
- Own the product roadmap, backlog, and delivery priorities for PLM, QMS, and Regulatory platforms.
- Gather, analyze, and document business requirements, user stories, process flows, and acceptance criteria.
- Partner with business leaders, IT, and vendors to design, implement, and enhance digital solutions.
- Support quality and regulatory processes including product lifecycle, change control, CAPA, deviations, audits, complaints, and regulatory documentation.
- Lead testing activities including SIT, UAT, validation, defect resolution, and production releases.
- Ensure solutions comply with SDLC, Agile, GxP, FDA 21 CFR Part 11, and Computer System Validation (CSV) requirements.
- Drive continuous improvement by monitoring adoption, user feedback, and platform performance.
Qualifications
- 7+ years of experience as a Product Owner, Business Analyst, or Systems Analyst in a regulated environment.
- Hands-on experience with Veeva Vault RegulatoryOne, Product Lifecycle Management (PLM), and Quality Management Systems (QMS) is required.
- Experience supporting regulated R&D, Quality, or Regulatory organizations.
- Strong understanding of Agile methodologies, backlog management, requirements gathering, and software delivery.
- Experience with CSV, GxP, FDA 21 CFR Part 11, and validation documentation.
- Familiarity with Jira, Azure DevOps, ServiceNow, Power BI, Visio, SharePoint, or similar tools.
Preferred Skills
- Excellent communication and stakeholder management skills.
- Strong analytical and problem-solving abilities.
- Ability to translate complex business and regulatory requirements into scalable technical solutions.
- Experience working with cross-functional teams in fast-paced, highly regulated environments.
- Dice Id: 91173046
- Position Id: 9046917
- Posted 13 hours ago
Company Info
About Asterism IT Solutions
Asterism IT Solutions is a global IT services and consulting firm. Relationships. It’s what drives us. We believe in building strong, long-lasting partnerships with our clients and technology professionals. Our team connects top talent with leading organizations through a wide range of technology solutions, helping businesses grow—and careers thrive.
We find the right fit for our candidates across contract, contract-to-hire, and direct placement opportunities in software development, cloud, security, and more.
Tech professionals with strong technical skills and a vision for long-term career growth will feel right at home with Asterism.
For clients, Asterism offers flexible IT Staffing Services, helping you scale quickly with experienced professionals to support critical projects, address workload spikes, and meet specialized skill needs. Our Direct Hire services ensure permanent placements for key technical and leadership roles. We also deliver strategic IT Consulting—providing expert guidance on project planning, technology strategy, and execution across enterprise systems
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