Jobdescription Your Role Maintain the Quality systems strategy and related SOPs Ensure that the relevant procedures are implemented and periodically reviewed, as well as monitor and implement best practices and legislations. Support continuously improve the QMS related to her areas of responsibility and coordinate relevant training activities. Collaborate with the Operational teams to ensure that all the activities meet quality specifications. Participate to and approve the risk assessments related to her areas of responsibility. Support the quality review and approval of Documentation system. Support Health Authorities inspection, internal and/or external audit, and support the evaluation and execution of actions with the Global Response Team (GRT). Ensure the training for other quality systems as a back up (if applicable) to ensure the flexibility of the overall QMS team Qualifikationen Your Profile Minimum bachelor''s degree in a scientific discipline and 2 5 years of experience in a pharmaceutical/biotechnology environment. Experience in establishing or improving QMS systems as an operational SME. Basic knowledge of Health Authority regulations. Experience in the usage of IT systems (CARA, TW, GxP Manager, GLIMS, SAP Lean etc.) Excellent communication skills, flexible team player, curious to learn, and proactive in sharing and collaborating. Analytical and problem solving abilities, as well as proactive approach to all aspects of quality. Organized and logical in defining workload and delivering project Fluency in English is mandatory; knowledge of French is a plus.