What are the responsibilities and job description for the Veeva Vault Regulatory Product Owner position at Spadtek Solutions LLC?
Job title: Veeva Vault Regulatory Product Owner
Location: Ewing, NJ
Work Arrangement: Hybrid – Onsite 3 days a week
Local Candidates: Required
Job Summary
We are seeking a Technical Product Owner 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
- 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.