Global Clinical Order Manager

vor 6 Monaten

Kaiseraugst, Schweiz We make it GmbH Vollzeit

We make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of competence in the personnel services sector.

Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT.

We make it GmbH places the highest demands on quality, ethics and discretion.

For our client, the company F. Hoffmann La Roche based in Kaiseraugst, we are looking for an Order Manager (M/F/d).

Background

As part of PTDS Global Clinical Supply Chain Management, the Production Enablement function ensures that packaging operations can produce material required by Roche’s clinical trials seamlessly, on-time, and while optimizing cost/quality. Within Production Enablement the Global Clinical Order Management team is responsible for preparing any kind of packaging orders that will be produced at our clinical packaging facilities in Kaiseraugst, South San Francisco or externally with our Contract Manufacturing Organization (CMO) partners. The Global Clinical Order Manager drives the operational coordination and on-time execution of packaging orders of Investigational Medical Products (IMPs) for global and local studies. The GCOM focuses on all final pack-orders within the packaging horizon, that is, from conversion of planned orders into process orders, handover to manufacturing until QA release. This includes an effective and efficient set-up of standard clinical packaging designs as well as the coordination of the material availability in collaboration with support groups to ensure a timely production until QA release in alignment with local standards and regulatory requirements. The GCOM is responsible for all tasks related to packaging order management within the planning time fence.

Aufgaben
- Ensure smooth handling of primary and secondary packaging orders in the packaging horizon and a timely global supply of clinical trials with IMPsEnsure smooth handling of primary and secondary packaging orders in the packaging horizon and a timely global supply of clinical trials with IMPs
- Managing in-house packaging orders and driving the “on-time in-full” delivery of those.
- In close collaboration with the Contract Manufacturing Organization (CMO) Site Manager, the GCOM manages outsourced packaging orders
- Is accountable for the set-up of Standard Packaging Designs in cooperation with the Global Production Enablement Leader (GPEL), Study Planner, Head of Operations, and Global IMP QA.
- Responsible for escalating any major in-house/outsourced packaging-related issue with impact to the end-to-end timeline to the GPEL or CMO site manager
- Drives and leads the issue management of in-house/outsourced packaging orders within the packaging horizon after handover until final release by IMP QA and works on process improvements for packaging topicsActively participates in regular meetings with GPEL, Quality Units, and other Clinical Supply OperationManagement teams. Is responsible to address all resupply packaging-related issues and drives thesolution implementation for those
- Actively monitors in-house and outsourced packaging coordination-related metrics and initiates improvement actions for any Key Performance Indicator (KPI) under target
- Responsibility for all operational parts of studies with regards to in-house and outsourced packaging orders
- GCOM is the first point of contact for operations. He/She briefs the Operations team with packaging instructions
- Actively monitors Key Performance Indicators (KPIs) for team performance, production readiness and order management activities and works independently to develop ideas and initiates continuous improvements according to the Roche PT Lean Production System (LPS) initiative
- Collaborate with Business Process Managers to exchange ideas, drive process improvement, and resolve issues on a global level. Supports system improvements, creates and revises SOPs and training documents

Qualifikation
- Associate level of professional education or University degree preferably in Supply Chain Management and/or Healthcare Management (\*\*\*\*\*)
- 3+ years experience in the pharmaceutical, biopharmaceutical industry and/or Supply Chain Management (\*\*\*\*\*)
- Ability to adhere to procedures and standards in a GMP environment (\*\*\*\*\*)
- ERP system experience, e.g. SAP, OMP or APO (\*\*\*\*\*)
- fluent in German and English
- Solid understanding of the Pharma Supply Chain and clinical packaging processes
- Well-developed teamwork, collaboration, and negotiation skills
- Possess strong problem solving and decision making skills, high attention to detail, and understanding of systems and technical designs
- Ability to work independently and set priorities. Self-motivated, proactive, quick thinking, adaptable

Nice to haves
- PMP/Operational Excellence/Six Sigma/Lean training a plus
- APICS and/or SCOR certification, or associated relevant ex

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