Inserat online seit: 12 Juni
Aufgaben der Stelle
Home Office: Up to 1 day per week, aligned with the Line ManagerDepartment: Global Clinical Order Management – PTDSBackgroundWithin PTDS Global Clinical Supply Chain Management, the Production Enablement function plays a key role in ensuring that clinical packaging operations can deliver trial materials reliably, on time and in line with cost and quality expectations.The Global Clinical Order Management team is responsible for preparing various packaging orders for Roche’s clinical packaging sites in Kaiseraugst and South San Francisco. The role supports the smooth execution of packaging activities for Investigational Medicinal Products and contributes directly to clinical trial supply readiness.Role PurposeWe are looking for a highly organised and proactive Clinical Supply Specialist with strong experience in clinical supply chain operations, order management and ERP systems such as SAP, OMP or APO.The role requires a detail-oriented person who can take ownership of packaging orders, coordinate with multiple stakeholders and ensure timely delivery in a GMP-regulated environment. A strong quality mindset, solid communication skills in German and English and the ability to manage operational topics independently are essential.Experience with Veeva, deviation handling, CAPAs, change records or continuous improvement initiatives is considered a strong advantage.Main ResponsibilitiesManage in-house packaging orders and support the on-time, in-full delivery of Investigational Medicinal ProductsCoordinate the set-up of Standard Packaging Designs together with Clinical Supply Chain Leads, Production Enablement teams, Master Data Deployment, Packaging Operations and Quality UnitsMonitor operational order execution and resolve packaging-related issues or discrepancies in collaboration with QualityEscalate major packaging-related risks or issues that may impact the end-to-end clinical supply timelineSupport and enable the medication randomisation process for blinded clinical studiesWork in a GMP-relevant environment and ensure compliance with applicable procedures and quality standardsContribute to process improvements and support lean or continuous improvement activities where applicableRequired ProfileBachelor’s degree in a relevant fieldMinimum 3 years of experience in clinical supply chain managementStrong experience with ERP systems, ideally SAP, OMP or APOExcellent written and verbal communication skills in German and EnglishStrong operational mindset with high attention to detailAbility to work independently, take ownership and follow through on tasksSolid GMP understanding and quality awarenessComfortable working with cross-functional stakeholders in a regulated environmentNice to HaveExperience with Veeva, especially deviations, CAPAs and change recordsSix Sigma, Lean training or practical continuous improvement experiencePrevious experience with clinical packaging orders or Investigational Medicinal ProductsExperience supporting blinded studies or medication randomisation processesIdeal CandidateThe ideal candidate brings a strong clinical supply chain background combined with hands‑on order management experience and excellent ERP knowledge. They are structured, reliable and proactive, with the ability to manage packaging‑related activities in a complex GMP environment.They communicate confidently with internal stakeholders, understand the importance of quality and timelines in clinical supply, and are motivated to contribute to efficient, compliant and reliable delivery of clinical trial material.
#J-18808-Ljbffr