Technical Product Owner, PLM, QMS & Regulatory

Role: Technical Product Owner, PLM, QMS & Regulatory

Location: Canada, Remote

Contract

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 the primary business-facing partner for PLM, QMS, and regulatory digital capabilities, balancing stakeholder needs with enterprise standards and platform strategy.
• Facilitate prioritization, decision-making, issue resolution, and trade-off discussions with business leaders, IT delivery teams, vendors, and governance forums.
• Monitor adoption, feedback, incidents, recurring pain points, and enhancement demand to inform backlog priorities and continuous improvement opportunities.

Experience

• 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.
• Strong 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.
• Familiarity with PLM, QMS, RIM, document management, reporting, analytics, integration, and workflow automation tools.
• Experience with tools such as Jira, Azure DevOps, ServiceNow, Power BI, Visio, Miro, SharePoint, or similar platforms.

Soft Skills

• Strong executive communication, facilitation, and stakeholder management skills.
• Ability to bridge business process, regulatory requirements, quality expectations, and technical solution design.
• Strong analytical thinking, structured problem solving, and ability to simplify complex cross-functional processes.
• Comfortable influencing without authority and driving alignment across business, IT, vendor, and governance teams.
• Ability to manage competing priorities, make value-based trade-offs, and deliver in a fast-paced regulated environment