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Director Quality Operations Development Programs & LCM (m/f/d)

Fresenius Kabi Austria GmbH -
Graz, ST

Jetzt bewerben

Details zur Stelle

Vollzeit

Qualifikationen

Doktorat
Master
Bachelor

Vollständige Stellenbeschreibung

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 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

Our expectations

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

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 € 75,000; 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

Fresenius Kabi Austria
Mag. Celina Gößler, MA
Hafnerstraße 36
8055 Graz

Jetzt bewerben

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