Simone Hubo
Senior Director Quality & Regulatory Compliance Ehs Eu Us @Crown Bioscience
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WORK HISTORY
Senior Director Quality & Regulatory Compliance Ehs Eu Us @Crown Bioscience
Hamburg, DE
As the Senior Director of Quality & Regulatory Compliance + EHS EU.US, I am responsible to ensure that the multi-site Quality Management System (QMS) at Crown Bioscience Germany GmbH remains accredited, certified, and compliant with medical guidelines such as CAP, ISO (9001, 15189), GxP (GCP, GLP), and ICH standards. This role aims for the company\'s growth by coordinating with local and corporate management, while providing input on quality, regulatory affairs, risk management and EHS (Environmental, Health, and Safety) issues across EU and US sites of Crown Bioscience.
EDUCATION
University of Hamburg
PhD, Neural Signaltransduction
University of Hamburg
Master of Science - MS, Biochemistry and Molecular Biology
ABOUT SIMONE HUBO
I am pleased to announce that I was promoted to Senior Director Quality & Regulatory Affairs + EHS EU.US at Crown Bioscience Germany GmbH as of April 1st, 2025, representing a CRO on a global level as Crown Bioscience being part of the JSR Life Sciences division.My function aims to ensure the multiple accredited, certified and compliant status of the Multi-Site and Integrated Quality Management System (IQMS), covering but not limited to Crown Bioscience Germany GmbH, taking into account all relevant medical guidelines, e. g. ICH, ISO (9001, 15189 and higher) GxP (clinical) as well as CAP/CLIA standards. To serve and support the ambitious growth strategy of this internationally minded, future-oriented company, as the Senior Director Quality & Regulatory Affairs + EHS EU.US I will coordinate with all departments, while providing upon request input into all upcoming quality & regulatory as well as EHS topics and serve as a matrix function as well as an internal consultant for the Global Biospecimen Solutions approach (GBSS/ Quality).
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