Director Quality Operations Development Programs & LCM (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 Director Quality Operations Development Programs & LCM (m/f/d) Ihr Aufgabengebiet • 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 Drug Substance, Drug Product and/or Combination Product by authoring, reviewing, approving, as applicable, protocols, plans and reports (e.g. Validations) and identify the risks and establish appropriate mitigation plan • 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 • Act on behalf of Senior Director Quality Operations with regards to subjects related to Quality Operations and Quality Life-Cycle Management Wir erwarten • A BA/BS, MA/MS or PhD in a technical or engineering discipline or related field • Minimum 10 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 • 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 75,000; higher salary depending on qualifications) JETZT BEWERBEN