25 km

MorphoSys AG


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Associate Director (gn) Quality Assurance Operations
Aktualität: 27.11.2021


27.11.2021, MorphoSys AG
Associate Director (gn) Quality Assurance Operations
Representation and strategic decisions for QA at project team meetings and regular calls with vendors Continuous improvement of our internal quality management system based on LEAN principles Write/review Quality Assurance SOPs, and review of SOPs and controlled documents related to IMP topics Write/review Quality Agreements Provide expert advice in GMP (secondary packaging) and GDP (storage & distribution) to MorphoSys internal procedures within relevant departments (e.g. Global Supply Chain, Clinical Operations, CMC) Provide IMP-related GDP / GMP support, advice, education and training to other departments involved in clinical trials and GDP/GMP QA activities Manage GDP / GMP deviations, changes, and complaints occurring at external Contract Packaging and Transport Organizations and CAPA follow-up Support preparation and active participation in authority inspections Perform selection and qualification of new GDP / GMP vendors Plan, perform and follow-up audits of GDP / GMP vendors
Sound knowledge in international regulations and guidelines EU / FDA cGMP regulations, GDP guidelines, ICH etc. Familiar with all GMP / GDP aspects relevant for set-up of clinical trials Well-organized, structured person with attention to detail Excellent communication skills, fluent in English (written and spoken) Flexible, highly motivated, with strong organization skills Works collaboratively in multi-functional teams as a key player with strong interpersonal and communication skills Able to work independently and solution-oriented Excellent application of office software (Word, Excel, PowerPoint and SharePoint) Experience with VEEVA or other Quality Management systems is desirable