Technical Product Owner - PLM, QMS and Regulatory Systems

Technical Product Owner – PLM, QMS & Regulatory Location: Remote Job Type: Contract Experience: 10+ Years Mandatory Skills: Product Ownership, PLM, Regulatory, Veeva Vault RegulatoryOne, QMS Position Summary We are seeking an experienced Technical Product Owner – PLM, QMS & Regulatory to own and evolve digital and AI-enabled product capabilities supporting Product Lifecycle Management (PLM), Quality Management Systems (QMS), and Regulatory processes across global R&D. The ideal candidate will combine strong Product Ownership and Business Analysis expertise with hands-on experience in Veeva Vault RegulatoryOne, PLM, and QMS environments. This role will translate complex business and regulatory needs into clear requirements, prioritized backlogs, validated solutions, and scalable digital capabilities. The individual will serve as a key liaison between R&D, Quality, Regulatory, IT, technical teams, vendors, and governance stakeholders to deliver compliant, user-focused, inspection-ready solutions that improve process efficiency, data quality, and cross-functional visibility. Key Responsibilities Product Ownership & Roadmap Management Own the product vision, roadmap, backlog, and delivery priorities for PLM, QMS, and Regulatory digital capabilities.Prioritize enhancements, defects, integrations, and technical debt based on business value, compliance risk, user impact, and delivery capacity.Define product outcomes, success measures, KPIs, and value-realization metrics.Partner with business leaders to translate strategic objectives into actionable product increments, releases, and continuous improvement initiatives.Drive backlog refinement, sprint planning, release planning, and prioritization activities.Regulatory Business Analysis & Requirements Lead discovery sessions, stakeholder interviews, workshops, and process reviews to identify business, functional, technical, data, reporting, and compliance requirements.Create business requirements, user stories, acceptance criteria, process flows, data requirements, decision points, and current-state/future-state process models.Translate complex regulatory processes into actionable requirements for configuration, workflow automation, reporting, integrations, and analytics.Conduct gap assessments between business requirements, platform capabilities, regulatory expectations, and existing processes.Ensure requirements are complete, testable, traceable, and aligned with business objectives and validation requirements.PLM, QMS & Regulatory Process Enablement Support end-to-end digital processes across Product Lifecycle Management, specification management, change control, quality events, deviations, CAPA, audits, complaints, registrations, submissions, claims, and regulatory documentation.Leverage hands-on knowledge of Veeva Vault RegulatoryOne, PLM, and QMS to support process optimization and digital transformation.Identify opportunities to simplify manual processes, eliminate duplicate data entry, improve data quality, and strengthen governance and compliance controls.Collaborate with R&D, Quality, Regulatory, Operations, and IT teams to improve cross-functional process visibility.Solution Delivery, Testing & Validation Partner with technical teams, vendors, and platform owners to design, configure, test, validate, and deploy scalable solutions.Lead or support SIT, UAT, regression testing, defect triage, release readiness, cutover planning, and post-go-live hypercare.Support Computer System Validation activities, including user requirements, functional specifications, risk assessments, test scripts, traceability matrices, approvals, and validation evidence.Ensure product changes comply with SDLC, Agile delivery, change control, cybersecurity, data privacy, quality, and regulatory requirements.Support inspection and audit readiness for validated systems.Stakeholder Engagement & Governance Serve as the primary business-facing product partner for PLM, QMS, and Regulatory digital capabilities.Facilitate prioritization, decision-making, issue resolution, and trade-off discussions with business leaders, IT teams, vendors, and governance forums.Monitor adoption, user feedback, incidents, recurring pain points, and enhancement requests to continuously improve the product backlog.Influence stakeholders without direct authority and drive alignment across business, technology, quality, and regulatory teams.Required Experience 10+ years of experience in Product Ownership, Business Analysis, Systems Analysis, or Technology Delivery within regulated environments.Hands-on experience with Veeva Vault RegulatoryOne.Hands-on experience with Product Lifecycle Management (PLM) and Quality Management Systems (QMS).Experience supporting PLM, QMS, Regulatory Information Management (RIM), document management, workflow, or enterprise quality/regulatory platforms.Strong understanding of product development, specification management, change control, quality events, deviations, CAPA, audits, complaints, submissions, registrations, claims, and regulatory documentation.Experience working with cross-functional teams across R&D, Quality, Regulatory, Operations, IT, and external vendors.Experience supporting validated systems, inspections, audits, and regulated technology delivery.Technical Skills Strong knowledge of Agile, hybrid delivery methodologies, SDLC, backlog management, user stories, acceptance criteria, and release planning.Hands-on experience creating business requirements, process maps, workflows, data flows, test cases, validation artifacts, and traceability matrices.Working knowledge of GxP, FDA 21 CFR Part 11, EU Annex 11, data integrity, audit trails, electronic records/signatures, and change control.Knowledge of PLM, QMS, RIM, document management, reporting, analytics, integration, and workflow automation platforms.Experience with tools such as Jira, Azure DevOps, ServiceNow, Power BI, Visio, Miro, and SharePoint or similar platforms.Strong understanding of system integrations, data flows, reporting, and digital workflow automation.Soft Skills Excellent executive communication, facilitation, and stakeholder management skills.Ability to bridge business processes, regulatory requirements, quality expectations, and technical solution design.Strong analytical thinking and structured problem-solving skills.Ability to simplify complex cross-functional processes and communicate effectively with technical and non-technical stakeholders.Comfortable influencing without authority and driving alignment across business, IT, vendors, and governance teams.Strong prioritization and decision-making skills with the ability to manage competing priorities in a fast-paced regulated environment.