Global Process Owner, Quality Management System, QMS Transformation
Ambu
Ballerup, Denmark with extensive global travel
Reports to
Global Operations Program Director, ERP, QMS & PLM Transformation, with dual reporting to VP Global Quality
Process area
Global Quality Management System, spanning quality governance, controlled processes and documentation, training, change management, validation, quality performance, and cross-functional QMS interfaces
Interfaces
Program Director, GBOs, other GPOs, Global Process Leads, Local Responsibles, functional and site leadership, IT, Finance, Quality, and implementation partners
Scale and technology
Global QMS across relevant legal entities, sites, functions, and users; Dassault Systèmes QMS/PLM and connected quality, validation, document, training, reporting, and data solutions
Position Summary
The Global Process Owner (GPO) for the Quality Management System is accountable for the global QMS process model, governance, and transformation outcomes. The role ensures that Ambu maintains an effective, risk-based, scalable, and compliant QMS that protects patients and product quality while enabling faster decisions, simpler ways of working, and global growth.
The GPO defines the future QMS operating model and ensures that processes and technology work as one coherent global system. The role moves quality upstream, strengthens lifecycle feedback, simplifies procedures and approvals, and balances global harmonization with applicable regulatory, product, site, and legal-manufacturer requirements.
Core Responsibilities
- Own the global QMS process vision, scope, standards, governance, roadmap, performance, and continuous improvement priorities in alignment with Quality Strategy and Project EQUIP.
- Define the global QMS operating model, process architecture, ownership, decision rights, controlled-document principles, training approach, change governance, validation requirements, and performance framework.
- Drive fit-to-standard QMS design, simplify and harmonize processes and documentation, remove non-value-adding bureaucracy, and enable risk-based controls and site empowerment within clear guardrails.
- Ensure integration across design and development, supplier quality, manufacturing and process quality, distribution and service, post-market surveillance, complaints, CAPA, change management, and management review.
- Partner with Quality, Regulatory, R&D, Operations, IT, and business process owners to translate regulatory and business requirements into scalable QMS capabilities, data, controls, workflows, and records.
- Mobilize process owners, quality experts, site representatives, and Local Responsibles; ensure validation, test coverage, migration and archiving readiness, training, deployment, adoption, and post-go-live control effectiveness.
- Mobilize and govern: Approved global QMS process architecture, scope, governance, ownership model, design principles, controls, and decision rights.
- Design: Fit-to-standard QMS requirements and design decisions covering workflows, documents, records, training, change, validation, data, reporting, and cross-functional interfaces.
- Build and test: Validated critical scenarios, migration and archiving approach, test evidence, procedures, training, cutover, and global and site readiness.
- Deploy and adopt: Post go-live governance, management-review and KPI cadence, stabilization, compliance monitoring, procedure simplification, adoption, and continuous improvement roadmap.
- Senior experience in Quality Management Systems, quality assurance, regulatory compliance, or enterprise quality transformation within medical devices, life sciences, or pharmaceuticals.
- Strong knowledge of ISO 13485, applicable medical-device quality-system requirements, GxP principles, validation, controlled documentation, CAPA, change management, audits, training, and management review.
- Demonstrated delivery of global QMS process design or digital QMS/PLM transformation; Dassault Systèmes or comparable eQMS experience is advantageous.
- Ability to translate strategy and regulatory or business requirements into scalable global processes, roles, data, controls, system capabilities, and measurable outcomes.
- Bachelor’s or Master’s degree in a relevant discipline, or equivalent professional experience.
Strong executive presence, process judgment, communication, and stakeholder-management skills. Able to lead through influence, resolve global and local trade-offs, bridge business and technology, challenge constructively, and create clarity across a complex global matrix. Flexibility to travel internationally during design, pilot, deployment, and stabilization.
What We Offer
Ambu offers an international, collaborative workplace where individual contributions matter. The role provides an opportunity to shape a major global transformation while benefiting from professional development, employee benefits, and challenging work supporting Ambu’s ambitious growth.