ITM Isotope Technologies Munich SE
Location
Garching bei München | Germany
Job description
About ITM 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 vacancy as soon as possible: Clinical Quality Assurance Associate (f/m/d) Your Role: Support quality assurance activities to ensure GCP and other regulatory requirements are met including but not limited to Assist in deviation management including CAPA management and follow-up Assist in audit management activities (internal, investigator site, vendor) Support GCP sponsor inspections by regulatory authorities Work collaboratively with other GxP QA personnel and cross-functionally to assist in maintaining a fit-for-purpose, compliant, and fully integrated ITM QMS Support the provision of GCP training Prepare data and metrics supporting ITM Quality Management Reviews Support cross-functional teams to establish and maintain processes in the Clinical Development and Clinical Operations departments Support the organization by gathering the most up to date regulatory intelligence related to clinical trials and observational studies What we are looking for: Undergraduate degree (Bachelor) or comparable education in nursing, life sciences or similar Ideally, at least two years of relevant experience in clinical operations, CRO experience preferred Experience with electronic Trial Master File and electronic Document Management System Excellent verbal and written communication skills in English (German would be an asset) Detail oriented but pragmatic Service- and solution-oriented Quality mindset Strong interpersonal relationship and collaboration skills working within cross-functional teams Organized, self-directed and efficiency-minded working style Flexible with changing priorities and able to work in a consistently changing environment What we offer: A modern workplace and exciting opportunities in an evolving and fast-growing company Challenging and varied projects in interdisciplinary, multicultural and highly professional teams A collegial corporate culture and short communication channels Flexible working hours with an attractive salary package and diverse corporate benefits At ITM, we work together towards one common goal – the benefit of our patients. This is what drives us, every day. This is what we are passionate about. For this we create opportunities that are as unique as our team. We encourage diversity and inclusion – the input of our multicultural employees makes us who we are. Only together we can contribute to significantly improving the outcome and quality of life of cancer patients worldwide and to giving better answers than “maybe”. Does this sound like you? Are you interested in shaping the future of ITM and joining one of our highly committed teams in an innovative work environment? Then send us your detailed CV including earliest start date and salary expectations. The position is intended for the ITM Isotope Technologies Munich SE, a company of the ITM group. Contact for your application: ITM Isotope Technologies Munich SE Human Resources Walther-von-Dyck-Straße 4 85748 Garching / Munich, Germany E-Mail: [email protected] Phone: +49 89 3298986-1709 Contact: Nadine Suerken For more information please visit:
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