QA Manager Combination Product and Device (m/f/d).

For our client, an international pharma company in Basel, we are looking for a QA Manager Combination Product and Device.


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.



General Information:
 

• Start date: ASAP
• Latest Start Date: 01.02.2025
• Duration: unlimited
• Workplace: Basel
• Workload: 80-100%
• Home Office: max. 2 days per week
• Team: 11 team member
• Department: Global Device Quality (MMQD)

Tasks & 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 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