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