EINFÜHRUNG:
As a preferred supplier for F. Hoffmann - La Roche Ltd. in Basel, we are looking for a motivated
QA Manager Combination Product and Device (m/f/d)
This is a full/part-time position (80-100%) with an unlimited duration. The ideal start date is asap or 01.02.2025. Remote/Home Office: max. 2 days per week.
AUFGABENBESCHREIBUNG:
* Serve as the Quality SPOC (single point of contact) for allocated Device Development project and ensure all projects follow the applicable design control and risk management procedures
* Collaborate with all QA representatives from other functions to ensure Quality Robustness of the interface between the Drug Product and the Device Component forming the Combination Product
* Create and deploy Risk Management Plan / Report, actively participate up to facilitating FMEAs, define Delivery System specifications accordingly including Drug Product / Component interface, and ensure all necessary release GMP documentation are completed and in place
* Ensure and drive quality resolution for investigations related to the delivery system, and assessment of change controls. Represent department at Quality Review Board and Change Review Board meetings
ERFORDERLICHES PROFIL:
* BS degree in Life Sciences discipline or mechanical engineering, Graduate degree preferred
* Min. 2 years experience and hands on expertise in device quality or device development ****
* Demonstrated capability of applying risk management concepts and tools, and deploying Design Control
* Understanding of the biotechnology industry and specifically combination products and working in a global environment preferred ****
* Sound knowledge of cGMPs and relevant international regulatory requirements (QSR; MDR; ISO13485, etc.)
* Well developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing
* Demonstrated problem solving and decision making skills including hands on working experience with tools Six Sigma / DMAIC is preferred
* Very motivated and willing to perform tasks with varying complexity
* Fluent in English, German is a plus
Application process
Interested? You can find more information here: