QMS Technical Workstream Lead 1

Freelio; Denmark; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Ambu seeks a QMS Technical Workstream Lead to own the technical backbone of a QMS workstream. You will co-lead with the GPO/GPLs, ensure process-system alignment, and deliver decision-ready designs with disciplined delivery and operational readiness across architecture, integrations, data migration, and releases.

You will drive technical governance, RAID, environments, CI/CD pipelines, and security/privacy controls, collaborating with QA/Validation Lead and external vendors to deliver

Qualifications

• 8+ years delivering technical workstreams on enterprise platforms (ERP, QMS, PLM) or similar.
• Strong leadership of architecture, integrations (API/iPaaS), data migration, and release management.
• Adeft in non-functional requirements: performance, reliability, security, privacy, SoD, and CSV validation.

Responsibilities

• Own the technical backbone for the QMS workstream and coordinate with GPO/GPLs and Business Workstream Lead.
• Lead technical governance, RAID management, and design packs for decision-ready review.
• Design, build, environments, releases, and data migration plans for QMS scope.
• Ensure cybersecurity, privacy, SoD, and CSV compliance in collaboration with QA/Validation Lead.
• Drive hypercare delivery, documentation, and knowledge transfer.
• Coordinate internal platform teams and external vendors to deliver high-quality global solutions.

Job description

# QMS Technical Workstream Lead 1Ansøg hos virksomheden## JobbeskrivelseQMS Technical Workstream LeadOwn the technical backbone for your workstream. As the Technical Workstream Lead for a specific business workstream (e.g. Quality/QMS), you sit side-by-side with the Global Process Owner (GPO) and Global Process Leads (GPLs) to translate process design into robust and scalable technology across QMS. You lead the technical scope for your workstream - architecture, build, environments, integrations, data migration, non-functionals, security/compliance, releases, and hypercare – through stage gates to successful handover.Ambu is transforming our core enterprise platforms (e.g., ERP, QMS, PLM), and each workstream needs a dedicated technical leader to ensure high-quality, compliant delivery that enables standardized, high-performing global processes. This job ad regards the QMS Workstream Lead Position The roleYou are the end-to-end technical owner of the QMS workstream. You co-lead the workstream together with the Business Workstream Lead/GPO, ensuring process-system alignment, decision-ready design, disciplined delivery, and operational readiness for your scope. QMS technical workstream lead• Experience in implementing QMS systems• Good understanding of workflows normally used within QA across the value chain• Good understanding of the system landscape needed to support QA via the QMS• Good understanding of the complex data and data structures used in product developmentKey responsibilities• Technical governance within your workstream• Run technical governance for the workstream. Prepare decision-ready design packs and status for the Design Authority• Own the workstream technical RAID (Risks, Assumptions, Issues & Dependencies). Assess run-time/architecture risks, define mitigations, and escalate with clear options• Safeguard solution integrity against enterprise standards and non-functional requirements• Design, build, environments, and release engineering• Lead technical design for your workstream: integrations, extensions, data model, security roles, automation• Define and manage environments for the workstream: branching strategy, CI/CD pipelines, and code quality gates• Manage technical debt, versioning, and change control with impact analysis across upstream/downstream systems• Data migration and cutover• Plan, prepare and execute migration tooling, trial loads, reconciliations/ validation, and cutover steps for your workstream objects• Security, privacy, and compliance• Ensure cybersecurity, privacy, Segregation of Duties (SoD), and validation/CSV compliance in collaboration with QA/Validation Lead• Delivery orchestration and hypercare• Coordinate internal platform teams and external vendors for your scope• Lead hypercare triage and stabilization for the workstream. Complete documentation and knowledge transfer to run• Program collaboration• Partner daily with the GPO, GPLs, and Business Workstream Lead; align on scope, decisions, and adoption• Work with PMO on stage gates, quality reviews, plans, and dependencies to other workstreamsYour profile• 8+ years delivering technical workstreams on enterprise platforms (ERP, QMS, PLM or similar) in global settings• Proven leadership of architecture, integrations (API/iPaaS), data migration, and release management within a defined scope• Strong command of non-functionals: performance, reliability, security, privacy, SoD, and validation/CSV• Hands-on experience with CI/CD, environment strategy, branching, automation testing, and code quality• Adept at partnering with GPOs/GPLs to translate future-state processes into scalable solution designs• Skilled in vendor management and cross-team coordination. Clear, concise communicator in English• Willingness to travel across Ambu’s footprint and collaborate across time zonesNice to have• MedTech/life sciences background (GxP, ISO 13485, 21 CFR Part 11, CSV)• Exposure to PLM, QMS, Infor M3 or equivalent ERP, plus iPaaS/data platforms, and modern security frameworks• Experience with Agile-at-scale combined with stage-gate governanceKey stakeholders for your workstream• Global Process Owner and Global Process Leads• QA/Validation Lead• PMO• External implementation partners and software vendorsKey responsibilities following the transformation- Participate in approved global projects-Provide advice for standard system and best practices of QMS and related systems- Act as Service Delivery Manager and Subject Matter Expert in QMS in the IT Application Team- Configure and maintain Ambu's QMS system, ensuring alignment with business requirements and best practices.- Handle system configuration, unit testing, training, and documentation in accordance with standards in close cooperation with external partners.-Manage Life Cycle Management & release management-Coach and review work performed by peer professionals- Work across functions and cultures to deliver high-quality global solutions-Work independently to solve complex problems-Train Business Process Owners and other key users-Follow regulatory compliance Ambu – where your technical leadership mattersJoin a fast-growing, international company where your workstream leadership directly enables how we operate globally. We offer strong professional development and a competitive package of professional, social, and financial benefits.How to applySend your CV and a short note describing a program where you led the technical workstream for a specific domain from design through hypercare, including how you de-risked integrations, data migration, and non-functionals.