Manager Quality Systems (f/m/d)

About ITM

ITM Isotope Technologies Munich SE develops, produces, and distributes targeted diagnostic and therapeutic radiopharmaceuticals as well as radioisotopes for cancer treatment on a global scale. Our mission at ITM is to significantly improve the treatment success and quality of life of cancer patients through the development of targeted radionuclide therapies in the field of precision oncology.

To strengthen our team, we are looking for a Manager Quality Systems (f/m/d) for an unlimited position in Garching near Munich, with a hybrid work model, starting as soon as possible.

Your Responsibilities

• Responsibility for the establishment, maintenance, and continuous development of the site-wide quality management system (QMS), including the quality manual, central standard operating procedures (SOPs), and the Site Master File.
• Ensuring the compliance and regulatory conformity of all GxP-relevant documents regarding completeness, timeliness, control, and controlled access.
• Managing the complete lifecycle of GxP-relevant documents (e.g., SOPs, Master Batch Records, qualification documentation), including document review, versioning, release, and archiving.
• Support and further development of the electronic document management system, as well as support in the structured categorization, training assignment, and tracking of documents.
• Conception, maintenance, and further development of the site-wide GxP training matrix in close cooperation with the training managers of the departments; definition and coordination of training plans and associated role profiles (Learner Roles).
• Collection, analysis, and trending of quality-relevant key performance indicators (KPIs), including preparation and processing for QRB and QMR.
• Support of internal and external audits and regulatory inspections.
• Participation in global Quality Risk Management activities and site-wide initiatives to strengthen the "Right-first-time" culture.
• Active involvement in continuous improvement processes (CIP), particularly with regard to the optimization and further development of documented quality systems.
• Initiation and management of sub-projects within the Quality Unit.

Your Profile

• Completed scientific or technical degree (Pharmacy, Biology, Chemistry, or similar) or several years of experience in the pharmaceutical industry (GMP/GxP-regulated environment), ideally with a focus on quality systems, or a comparable qualification.
• Sound knowledge in the application of QMS/DMS systems (e.g., Veeva Vault, MasterControl).
• Experience in managing audits, inspections, and training management is desirable.
• Willingness to acquire additional qualifications and to undergo continuous training.
• Good communication skills, assertiveness, and teamwork skills, solution-oriented.
• Very good knowledge in quality assurance according to applicable GMP or cGMP and ICH guidelines.
• Very good German and English skills, both written and spoken.

What You Can Look Forward To:

• Exciting challenges in an aspiring and rapidly growing company with a high degree of creative freedom.
• An open work atmosphere in an international corporate culture with short communication channels.
• Comprehensive onboarding program.
• Flexible working hours with home office options.
• Attractive special payments.
• Simply good salary? Not with us! We also offer you:
  • Employee participation program.
  • Company bike or subsidy for a public transport ticket.
  • Above-average contribution to company pension plans.
  • Individually tailored further training (including German and English courses).
  • Health promotion offers (e.g., EGYM Wellpass, subsidy for local gym, support for sports events, various lifestyle coaching).

ITM is an employer that ensures equal opportunities. Qualified applicants are encouraged to apply and will be considered in the selection process regardless of gender, age, national or ethnic origin, religion or belief, disability, sexual orientation or gender identity, or any other characteristic protected by the AGG.

If you have a physical disability or are considered disabled according to § 2 Schwerbehindertenrecht and have difficulties with the online application, you can request appropriate support. Please contact career@itm-radiopharma.com for this purpose.

Please inform us of your earliest start date and your salary expectations with your application. You can submit your CV in German and English in docx or pdf format.

Contact

Leticia Rodriguez +49 89 329 8986-1706 career@itm-radiopharma.com

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

Note for Personnel Service Providers Please note that we do not accept unsolicited applications or offers of support. The phone number provided in the advertisement is exclusively for applicants and should not be contacted for other purposes. Thank you!

Learn more about ITM: You have the opportunity to work on pioneering projects in an international work environment that can have a significant impact on cancer treatment worldwide. We are looking for dedicated, talented, and passionate professionals who share our vision and want to contribute to shaping the future of oncology. If you are attracted by this exciting challenge and want to help us achieve our common goal, do not hesitate to submit your application. We look forward to hearing from you!

Further information about ITM can be found at: www.itm-radiopharma.com