QA Manager Combination Products (m/f/d)

Contract duration: 1 year, will be extended

Location: Basel

Workload: 100%

The perfect candidate has min. a bachelors degree in a life sciences discipline or mechanical engineering and 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.

Responsibilities:

• Serve as the Quality SPOC for allocated Device Development or commercial 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

Requirements

•  BS degree in Life Sciences discipline or Chemical/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