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Quality Assurance Project Manager

m/w/d, Basel-Stadt

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.

The perfect candidate has min. a bachelors degree in a life sciences discipline or mechanical engineering and min first experience in a GMP regulated environment. Expertise in device quality or device development is required, also demonstrated capability of applying risk management concepts and tools, and deploying Design Control.

Key Responsibilities:

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 meeting

Qualifications:

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.)