Senior Manager Quality Operations (m/f/d)

Fresenius Kabi Austria, with headquarters in Graz and further production site in Linz, is a subsidiary of Fresenius Kabi AG, a world leading manufacturer of infusion therapy and clinical nutrition products. Fresenius Kabi Austria has 1600 employees and ranges among the top enterprises of the region. Shortfacts • Einsatzort: Graz • Ausmaß: Full-time • Eintrittsdatum: ab sofort • Anstellungsverhältnis: unlimited We are caring for our employees • Reliable employer • Strong global growth • International career opportunities • Comprehensive education and training • Homeoffice • Jobticket • Active health promotion • Free parking space • Bikeleasing • Canteen • Joint company events Ihre Ansprechpartnerin Your contact person Fresenius Kabi Austria Mag. Celina Gößler, MA Hafnerstraße 36 8055 Graz karriere-fresenius-kabi.at Senior Manager Quality Operations (m/f/d) Your tasks • Maintain an up-to-date knowledge of cGxP regulation and applicable standards (especially in the US and EU) and implement requirements into locally applicable procedures (SOPs, Guiding Documents, Working Instructions, etc) • Manage a GMP compliant transition of Programs from development to commercial • Manage GMP compliance during Tech Transfer of manufacturing activities of Combination Product • Manage GMP compliance during Analytical Transfer activities • Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to Drug Substance, Drug Product and Combination Products • Contribute to QM programs and GMP/GDP/MDR compliance activities as appropriate • Manage GMP/GDP/MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers Our expectations • A BA/BS, MA/MS or PhD in a technical or engineering discipline or related field • Minimum seven years’ experience in a Quality function with increasing levels of responsibility in the biotech, lifescience or pharmaceutical industry • Strong understanding and interpretation of Quality Standards (such as ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10), cGMP requirements for Pharmaceuticals and Combination Products, including Biologic Products • Strong understanding of GMPs and best quality practices with regards to biotech manufacturing processes • Experience with regulatory agencies such as the FDA, EMA, etc. • Proven success in third-parties’ quality management • Excellent communication skills in English, both written and oral, French and German as an asset • Demonstrated ability to work effectively in a team-oriented environment • Demonstrated skills in Leadership, Drive, Intensity, Enthusiasm We offer • Highly varied range of tasks • Training opportunities and personal development within the company • Career opportunities in an international pharmaceutical company • Attractive, performance-based remuneration (minimum gross annual salary of € 60,000; higher salary depending on qualifications) Benefits • Reliable employer • Strong global growth • International career opportunities • Comprehensive education and training • Homeoffice • Jobticket • Active health promotion • Free parking space • Bikeleasing • Canteen • Joint company events