Clinical Quality Assurance Associate (f/m/d) - Befristet auf 2 Jahre

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 fixed-term (2 years) vacancy in a hybrid working model in Garching as soon as possible

Clinical Quality Assurance Associate (f/m/d) - Befristet auf 2 Jahre

Your role

• Assist in deviation and CAPA management, including follow-up actions


• Support audit management activities for internal, investigator site, and vendor audits


• Aid GCP sponsor inspections and collaborate with regulatory authorities


• Work cross-functionally with GxP QA personnel to maintain a compliant, integrated ITM QMS


• Support GCP training initiatives and prepare data for Quality Management Reviews


• Assist cross-functional teams in establishing and maintaining processes and gathering regulatory intelligence for clinical trials and observational studies

Your profile

• Bachelor’s degree or equivalent in nursing, life sciences, or a related field, with 2–5+ years of clinical operations experience (CRO experience preferred)


• Experience with electronic Trial Master File (eTMF) and electronic Document Management Systems (eDMS)


• Detail-oriented, pragmatic, and quality-focused mindset


• Strong interpersonal and collaboration skills for working in cross-functional teams


• Organized, self-directed, efficient, and adaptable to changing priorities and environments


• Excellent verbal and written communication in English (German language skills are a plus)

Our offer

• Exciting challenges in an up-and-coming and fast-growing company with a high degree of creative freedom


• An open working atmosphere in an international corporate culture with short communication channels


• Comprehensive onboarding programme


• Flexible working hours with home office options


• Attractive special payments


• Just a good salary? Not with us! We also offer you
  
  
  
  • Employee participation programme
  
  
  • Job bike or subsidised job ticket
  
  
  • Above-average contribution to the company pension scheme
  
  
  • Individually 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)
  
  
  
  

Do you have these qualifications, are you willing to develop yourself further and are you looking forward to becoming a key part of our future? Great! We should get to know each other!

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.

Contact

Anastasia Dauns

ITM Isotope Technologies Munich SE
Human Resources
Walther-von-Dyck-Str. 4
85748 Garching/München, Deutschland

Note for recruitment agencies
Please 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 ITM

With 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!

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