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

QA Manager Combination Product and Device m/f/d) - device quality/device development/Deplyig Design Control/cGMPs/QSR; MDR; ISO13485/Six Sigma/DMAIC/English/German

Project:
For our customer a big pharmaceutical company in Basel we are looking for QA Manager Combination Product and Device (m/f/d).

Background:
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.

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
* 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

Reference Nr.: 923737SDA
Role: QA Manager Combination Product and Device (m/f/d)
Industrie: Pharma
Workplace: Basel (Home Office: max. 2 days per week)
Pensum: 80 - 100%
Start: ASAP (Latest start Date: 01.02.2025)
Duration: unlimited
Deadline: 23/10/2024

If you are interested in this position, please send us your complete dossier via the link in this advertisement.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.