Manager (m/f/d) Quality Systems Support - GMQS, Bad Homburg

Mehr als 250.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

Your assignments

• Maintain and improve the quality management system and its certification status according to ISO9001, ISO13485 and the requirements
• Render support in the implementation of the Consolidated Quality Management System
• Compile documentation for notifications of changes according to the requirements of the Notified Body, certification body and authorities
• Develop and implement the change notification process and related instructions in the GMQS plants
• Establish and coordinate a working group/ Subject Matter Expert (SME) network in the plants within GMQS with regard to the change notification process
• Establish and maintain a central Company Profile related to Appendix 2 (e.g. critical supplier list) in coordination with the countries
• Render support in creating a quality system plan and pursuing quality targetsRender support in the definition and implementation of software tools
• Liaise with the regional process owners (POs) and the Corporate Audit Program

Your profile

• University degree in scientific or technical studies (e.g.: pharmacy, engineering)
• Several years of professional experience in a similar function within a pharmaceutical or MedTech company
• Very good knowledge of quality management and risk management standards (e.g. IS013485, IS014971, ICH Q10, FDA 21 CFR etc.)
• Expertise in drug regulations (GMP, AMG, AMWHV, etc.)
• Qualification as Qualified Person according to AMG §15 and / or § 11 ChemVerbots desired
• Knowledge of Enterprise Quality Management software (e.g. TrackWise)
• High sense of responsibility, strong communication skills with pronounced ability to work in a team
• High language proficiency German and English (spoken and written)
• Willingness to travel