Job Title: Technical Product Owner, PLM, QMS & Regulatory

Position: Remote - Canada

About the Role

This role combines product ownership with strong business analysis responsibilities—translating business needs into clear requirements, a prioritized backlog, validated solutions, and scalable digital capabilities across the R&D; landscape. Serving as a key liaison between business stakeholders, technical teams, vendors, and governance partners, you will deliver compliant, user-centered, inspection-ready solutions that improve process efficiency, data quality, and cross-functional visibility.

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 product outcomes, success measures, and value realization 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.

Qualifications

- 10+ years of experience in product ownership, business analysis, systems analysis, or technology delivery within regulated environments.




- Hands-on experience with Veeva Vault RegulatoryOne, Product Lifecycle Management (PLM), and Quality Management Systems (QMS).
- Experience supporting PLM, QMS, Regulatory Information Management, document management, workflow, or enterprise quality/regulatory platforms.
- 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.
- Preferred: Experience supporting validated systems, inspections, audits, and regulated technology delivery.

Required 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.

Preferred 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.

📌 Technical Product Owner, PLM, QMS & Regulatory (Canada)
🏢 KTek Resourcing
📍 Canada