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

Mag. Celina Gößler, MA

Hafnerstraße 36

8055 Graz

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