Veeva Vault Regulatory One Business Analyst
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Tek Inspirations LLC
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Job Details
Skills
- Acceptance Testing
- Agile
- Computerized System Validation
- Conflict Resolution
- Continuous Improvement
- Analytical Skill
- Auditing
- Business Analysis
- Change Control
- JIRA
- Communication
- Corrective And Preventive Action
- DevOps
- Documentation
- GxP
- Management
- Microsoft Azure
- Microsoft Power BI
- Microsoft SharePoint
- Microsoft Visio
- Plant Lifecycle Management
- Problem Solving
- Process Flow
- Product Lifecycle Management
- Product Ownership
- QMS
- Quality Management
- Requirements Elicitation
- Stakeholder Management
- System Integration Testing
- Research and Development
- Roadmaps
- ServiceNow
- Software Development Methodology
- Testing
- User Stories
- Veeva
Summary
Job Description -
Job Title: Veeva Vault Regulatory One Business Analyst
Location: Ewing, NJ. This role will be hybrid onsite 3 days a week- Locals Only
Exp Level: 12+ years
need local with DL and Linkeidn
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.
- 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: 91099133
- Position Id: 9047152
- Posted 12 hours ago
Company Info
TEK Inspirations LLC is a Texas based IT Staffing and consulting company that focuses on highly qualitative, timely delivered and cost-effective offshore software development and Staffing Services. We are committed to attracting, retaining and rewarding the best minds in the business. TEK Inspirations LLC is a place where people can grow and advance their career. We believe in an environment of integrity, trust, and sense of pride. We commit to attract & develop talent and retain a team of motivated & satisfied employees.
TEK Inspirations is committed to provide customer satisfaction through commitment & highest standards of qualitative services with minimum turnaround time. We have extensive experience in providing services to different domains like Healthcare, Pharmaceutical, Banking & Financial, and Telecom etc. We are highly focused to our customers in more ways than one. By improving reliability and agility, we enable our customers to achieve sustainable advantage over their competitors.
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