Job Summary
Key Responsibilities
Technical Product Owner, PLM, QMS & Regulatory Position Summary The Technical Product Owner, PLM, QMS & Regulatory will own and evolve the digital and AI product capabilities that support product lifecycle management, quality management, and regulatory business processes across global R&D. This role will combine product ownership with strong business analysis responsibilities, ensuring that business needs are translated into clear requirements, prioritized backlog, validated solutions, and scalable digital capabilities across the R&D landscape. The individual will serve as a key liaison between business stakeholders, technical teams, vendors, and governance partners to deliver compliant, user-centered, inspection-ready solutions that improve process efficiency, data quality, and cross-functional visibility. Key Responsibilities Product Ownership & Roadmap Management Own the product vision, roadmap, and backlog for PLM, QMS, and regulatory digital capabilities, aligned to business priorities and technology strategy. Prioritize enhancements, defects, integrations, and technical debt based on business value, compliance risk, user impact, and delivery capacity. Define clear product outcomes, success measures, and value realization of metrics for assigned platforms and capabilities. Partner with business leaders to convert strategic needs into actionable product increments, releases, and continuous improvement plans. Regulatory Business Analysis & Requirements Definition Lead discovery sessions, stakeholder interviews, workshops, and process reviews to elicit business, functional, technical, data, reporting, and compliance requirements. Document business requirements, user stories, acceptance criteria, process flows, data needs, decision points, and current-state/future-state operating models. Translate complex regulatory business processes into clear solution requirements for configuration, workflow automation, reporting, integrations, and analytics. Conduct gap assessments between business needs, platform capabilities, regulatory expectations, and current process performance. Ensure requirements are complete, testable, traceable, and aligned to business objectives, validation expectations, and system lifecycle controls. PLM, QMS & Regulatory Process Enablement Support end-to-end digital processes across product lifecycle management, , change control, quality events, deviations, CAPA, audits, complaints, registrations, claims, and regulatory documentation. Identify opportunities to simplify manual work, reduce duplicate data entry, improve governance, and strengthen compliance controls across processes. 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, approvals, and validation evidence. Ensure changes follow SDLC, Agile, change control, quality, cybersecurity, data privacy, and compliance expectations. Stakeholder Engagement, Adoption & Governance Serve as
Skill Requirements
Technical Product Owner, PLM, QMS & Regulatory Position Summary The Technical Product Owner, PLM, QMS & Regulatory will own and evolve the digital and AI product capabilities that support product lifecycle management, quality management, and regulatory business processes across global R&D. This role will combine product ownership with strong business analysis responsibilities, ensuring that business needs are translated into clear requirements, prioritized backlog, validated solutions, and scalable digital capabilities across the R&D landscape. The individual will serve as a key liaison between business stakeholders, technical teams, vendors, and governance partners to deliver compliant, user-centered, inspection-ready solutions that improve process efficiency, data quality, and cross-functional visibility. Key Responsibilities Product Ownership & Roadmap Management Own the product vision, roadmap, and backlog for PLM, QMS, and regulatory digital capabilities, aligned to business priorities and technology strategy. Prioritize enhancements, defects, integrations, and technical debt based on business value, compliance risk, user impact, and delivery capacity. Define clear product outcomes, success measures, and value realization of metrics for assigned platforms and capabilities. Partner with business leaders to convert strategic needs into actionable product increments, releases, and continuous improvement plans. Regulatory Business Analysis & Requirements Definition Lead discovery sessions, stakeholder interviews, workshops, and process reviews to elicit business, functional, technical, data, reporting, and compliance requirements. Document business requirements, user stories, acceptance criteria, process flows, data needs, decision points, and current-state/future-state operating models. Translate complex regulatory business processes into clear solution requirements for configuration, workflow automation, reporting, integrations, and analytics. Conduct gap assessments between business needs, platform capabilities, regulatory expectations, and current process performance. Ensure requirements are complete, testable, traceable, and aligned to business objectives, validation expectations, and system lifecycle controls. PLM, QMS & Regulatory Process Enablement Support end-to-end digital processes across product lifecycle management, , change control, quality events, deviations, CAPA, audits, complaints, registrations, claims, and regulatory documentation. Identify opportunities to simplify manual work, reduce duplicate data entry, improve governance, and strengthen compliance controls across processes. 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, approvals, and validation evidence. Ensure changes follow SDLC, Agile, change control, quality, cybersecurity, data privacy, and compliance expectations. Stakeholder Engagement, Adoption & Governance Serve as