About ITMITM 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 in Garching as soon as possibleDirector Clinical Quality Assurance/GCP (f/m/d)Your roleDevelop the GCP audit strategy and prepare the GCP Annual Audit ProgramPlan, conduct, report, and follow-up of internal system/process audits and external audits (vendors, investigator sites) in accordance with current SOP(s)Facilitate the coordination of regulatory GCP inspections by taking on hosting responsibilities and addressing inspection-related requestsSupport the coordination of Regulatory Inspections (GCP) by taking on the hosting responsibilities and facilitating any requestsProvide GCP expertise (interpretation and guidance), in collaboration with relevant internal functions to identify, assess, and communicate quality related risks and trends and improvement opportunities and provide input for mitigation activitiesGCP Deviation Management including CAPA ManagementYour profileDegree in life sciences or a healthcare-related disciplineMinimum of 8–12 years working in a GCP-regulated environment (e.g., Quality, Audit, Compliance)Proven track record in GCP readiness activities as well as in supporting or hosting inspections by Regulatory AuthoritiesExtensive background in conducting internal and external GCP audits (systems, processes, investigator sites, service providers)Strong proficiency in MS Office; skilled user of the Veeva Vault systemHighly organized, pragmatic, and detail-oriented, with the ability to drive and support continuous improvement while working both independently and in cross-functional teamsFluent in English; German language skills are an advantageOur offerExciting challenges in an up-and-coming and fast-growing company with a high degree of creative freedomAn open working atmosphere in an international corporate culture with short communication channelsComprehensive onboarding programmeFlexible working hours with home office optionsAttractive special paymentsJust a good salary? Not with us! We also offer youEmployee participation programmeJob bike or subsidised job ticketAbove-average contribution to the company pension schemeIndividually tailored further training programme (including German and English courses)Health promotion programmes (e.g. EGYM Wellpass, subsidy for local fitness studio, sponsorship of sporting events, various lifestyle coaching sessions)ITM is an employer that ensures equal opportunities. Qualified applicants are encouraged to apply and will be considered during the selection process regardless of gender, age, national or ethnic origin, religion or belief, disability, sexual orientation, gender identity, or any other characteristic protected under the German General Equal Treatment Act (AGG).If you are a qualified individual with a disability or are otherwise covered under applicable law and are unable to apply through our online application process, you may request a reasonable accommodation. Please contact .When you apply, please let us know your earliest possible starting date and your salary expectations. You can submit your CV in German and English in docx or pdf format.ContactAnastasia Daunscareer@itm-radiopharma.comITM Isotope Technologies Munich SEHuman ResourcesWalther-von-Dyck-Str. 485748 Garching/München, DeutschlandNote for recruitment agenciesPlease note that we do not accept unsolicited applications or offers of assistance. The telephone number given in the advertisement is intended exclusively for applicants and should not be contacted for any other purpose. Thank you very much!More about ITMWith us, you will have the opportunity to work in an international environment on ground-breaking projects that can have a significant impact on cancer care worldwide. We are looking for dedicated, talented and passionate professionals who share our vision and want to help shape the future of oncology. If this exciting challenge appeals to you and you would like to contribute to realising our common goal, please do not hesitate to send us your application. We look forward to hearing from you!For more information please visit: www.itm-radiopharma.com