In-Vitro Diagnostic Devices Quality Lead (M/F)
Posted: 09 Sep 2022
Do you remember a while ago, we had a fantastic position in Global QA? Well, this opening is even more fantastic! We are thrilled of helping UCB Medical Device find the right Talent to improve Patient's lives.
The main mission contains but is not limited to:
- Lead or support implementation of quality process improvement and maintain applicable QMS sections to ensure consistency and compliance to EU IVDR, US FDA and other territories;
- Train and influence UCB internal stakeholders to IVD requirements/processes in connection to Pharma and GCP and GLP processes;
- Participate to IVD's requirements definition, partners selection and monitoring;
•Oversee Design & Development activities to IVD partners;
- Interact as IVD's QA point of contact with Regulatory CMC & Devices, Pharmaceutical teams, Research Quality, Clinical, Biomarker team in early phase development and commercial organization.
- Master's degree in a relevant discipline (Pharmaceutical, Biomedical-Engineering, Biotechnology, Biology, or related fields);
- At least a solid first experience in Quality in IVDs or Medical Devices or Medical laboratories fields;
- od kledge of GLP and/or ISO environment;
- An audit experience is a big plus;
- Very good command of English.