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