Requirements: English
Company: WhatJobs
Region: Basel , Basel City
Jobdescription
For our client, a leading pharmaceutical company in Switzerland, we are looking for aQA Manager Combination Product and Device.
General Information:
Start date:01.07.2025
Latest start date:01.09.2025
Duration:unlimited
Workplace:Basel
Workload:80-100%
Remote/home office:Yes, max 2 days per week
Team:11 people
Department:Global Device Quality (MMQD)
Working hours:Standard
About the job:
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.
Your Profile:
You have 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.
Tasks & Responsibilities:
Serve as the Quality SPOC for allocated Device Development or commercial projects 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 the department at Quality Review Board and Change Review Board meetings.
Must Haves:
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
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
Sounds interesting?Apply now were looking forward to receiving your applications!
Application Submission Deadline:29.05.2025