Technical Product Owner, PLM, QMS & Regulatory 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.

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. 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.

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. Serve as the primary business-facing partner for PLM, QMS, and regulatory digital capabilities, balancing stakeholder needs with enterprise standards and platform strategy.

Monitor adoption, feedback, incidents,



recurring pain points, and enhancement demand to inform backlog priorities and continuous improvement opportunities. 10 + years of experience in product ownership, business analysis, systems analysis, or technology delivery within regulated environments. ~ Experience supporting PLM, QMS, Regulatory Information Management, document management, workflow, or enterprise quality/regulatory platforms. Must have hands on experience with Veeva Vault RegulatoryOne, Product Lifecycle Management and Quality Management Systems. ~ Solid understanding of product development, specification management, change control, quality events, CAPA, audits, complaints, submissions, registrations, claims, or regulatory documentation processes. ~ 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 preferred.

Technical Skills

Strong knowledge of Agile, hybrid delivery, SDLC, backlog management, user story writing, acceptance criteria, and release planning. Hands‑on experience documenting 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 expectations.

Experience with tools such as Jira, Azure DevOps, ServiceNow, Power BI, Visio, Miro, SharePoint, or similar platforms. Ability to bridge business process, regulatory requirements, quality expectations, and technical solution design.

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