(Senior) Manager Quality Operations Analytics (m/f/d)

Fresenius Kabi Austria, with headquarters in Graz and a 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 Vollzeit Eintrittsdatum ab sofort Anstellungsverhältnis unbefristet We are caring for our employees • verlässlicher Arbeitgeber • starkes globales Wachstum • internationale Karrieremöglichkeiten • umfassende Aus- und Weiterbildung • aktive Gesundheitsförderung • Gratis Parkplatz • Kantine • gemeinsame Firmenevents Ihre Ansprechpartnerin: Fresenius Kabi Austria GmbH Mag. Celina Gößler, MA Hafnerstraße Graz (Senior) Manager Quality Operations Analytics (m/f/d) Ihr Aufgabengebiet • Support GMP/GDP/MDR quality oversight (qualification, approval, monitoring) of C(D)MOs, Testing Labs, Medical Devices suppliers, packagers and carriers • Support Tech Transfer of Analytical Method and provide Quality Oversight for GMP compliant execution • Provide quality support to programs ensuring smooth transition from development to commercial • Manage Events (OOS/OOT/OOE), Changes (QC), related CAPAs liaising with the relevant functions of the Business Unit, Production Units (PUs) and Suppliers • Lead continuous improvement of quality processes associated to commercial medicinal products, such as, but not limited to, inspection readiness, internal & external audits, supplier management, documentation, changes / events, CAPAs, management reviews, recalls • Collect Key Quality/Compliance Indicators for periodic review of local Quality Management System • Monitor Quality Systems for trends and notify management of events requiring and immediate action Wir erwarten • A BA/BS, MA/MS or PhD in a technical or engineering discipline or related field • Minimum 4 years' experience in a Quality function with increasing levels of responsibility in the biotech, lifescience or pharmaceutical industry • Strong background in analytical sciences for biologics • Strong understanding and interpretation of Quality Standards (such as ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10), cGMP & GDP 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 as an asset • Demonstrated skills in Leadership, Drive, Intensity, Enthusiasm Wir bieten • 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 EUR 60,000; higher salary depending on qualifications) JETZT BEWERBEN