QA Manager Combination Product and Device 80-100%

Beschreibung

We are looking for a motivated and committed QA Manager Combination Product and Device for our client, F. Hoffmann-La Roche Ltd.

based in Basel, for a 12 month assignment with option for extension.

The Quality Project Manager position will provide in-depth Device Quality expertise for drug delivery systems (under development or commercial) to ensure compliance with applicable standards and regulations.

The position will be a support of the Quality SPOC (single point of contact) for the Device Development and Device Industrialization project team.

Tasks

• 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

Must Haves

• 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

Are you interested? Don't hesitate and send us your complete application documents online today.

We will also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!