Quality Project Manager

Quality Project Manager - Life Sciences/Biotechnology/GMP/Device Development

Project:

We are looking for an experienced Quality Project Manager specializing in combination products and devices to join our client's dynamic team. In this pivotal role, you will ensure the highest quality standards and compliance with international regulatory requirements, contributing to the development and management of innovative biotechnology products.

The perfect candidate has min. a bachelor's 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 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:

• In-depth experience and hands on expertise in device quality or device development
• Demonstrated capability of applying risk management concepts and deploying Design Control
• Understanding of the biotechnology industry and specifically combination products
• Experience in global environment preferred
• Sound knowledge of GMP and relevant international regulatory requirements (QSR; MDR; ISO13485, etc.)

Languages:

• German fluency is a plus
• English fluency (C1 / C2 Level)

Reference Nr.: 924220FC
Role: Quality Project Manager
Industry: Pharma
Work Location: Basel, Switzerland
Workload: 100%
Start: ASAP
Duration: unlimited

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

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.

ITech Consult AG
+41417607701