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

• 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

• Oversee internal audits and support external audits of U.S.-based vendors, partners, and operations

• Lead U.S. deviation management, CAPA, change control, document control, and training systems

• Act as the primary liaison between U.S. and global quality teams, ensuring strong alignment on strategy, priorities, and expectations

•  Drive quality-related communication and training to build awareness and foster a culture of quality and compliance

• Bachelor’s degree in Life Sciences, Pharmacy, Healthcare, or related discipline (advanced degree preferred)

• Minimum 5 years of quality assurance or compliance experience in pharmaceutical or biotech industries, including commercial and corporate function exposure

• Strong knowledge of U.S. regulations (FDA, OIG, PhRMA) and familiarity with global frameworks (ICH, EMA)

• Experience with enterprise QMS, policy governance, and managing quality systems across diverse business units

• Proven ability to collaborate globally and influence cross-functionally without direct authority

• Exceptional communication, organizational, and problem-solving skills

• Experience aligning U.S. operations with global quality systems in a multinational company

• Familiarity with commercial compliance topics such as promotional review, field force monitoring, and medical information governance

• Proficiency with electronic Quality Management Systems (eQMS) and document control platforms

• 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
  
  • Employee participation program
  • Individually tailored further training program

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 English in docx or pdf format.

Nadine Sürken

+49 89 329 8986 -1709

career@itm-radiopharma.com

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!

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!

For more information please visit: www.itm-radiopharma.com