Senior Technical Product Owner – PLM, QMS & Regulatory Systems

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.