Clinical Quality Assurance Associate
vor 1 Woche
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
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.
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