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ITM Isotope Technologies Munich SE

Head of Quality, US (f/m/d)

ITM Isotope Technologies Munich SE, Princeton, New Jersey, us, 08543

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ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM). We would like to fill the following permanent vacancy in a hybrid working model as soon as possible Head of Quality, US (f/m/d)

Provide quality oversight across all U.S. functions, including Commercial, Medical, Market Access, and Corporate Operations Maintain and enhance the U.S. Quality Management System (QMS) to ensure compliance with FDA, PhRMA, and other relevant regulatory frameworks Harmonize U.S. quality policies and procedures with global standards and directives from ITM SE in Germany Collaborate with Global Quality and Compliance leadership to roll out enterprise-wide initiatives, systems, and programs Manage the U.S. implementation of global audit programs, inspection readiness plans, and CAPA systems

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