GCP Audit Manager

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 permanent vacancy in a hybrid working model in Garching as soon as possible

Your role

• Develop the GCP audit strategy and prepare the GCP Annual Audit Program
• Plan, 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 requests
• Support the coordination of Regulatory Inspections (GCP) by taking on the hosting responsibilities and facilitating any requests
• Provide 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 activities
• GCP Deviation Management including CAPA Management
  
  

Your profile

• Degree in life sciences or a healthcare-related discipline
• Minimum 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 Authorities
• Extensive 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 system
• Highly organized, pragmatic, and detail-oriented, with the ability to drive and support continuous improvement while working both independently and in cross-functional teams
• Fluent in English; German language skills are an advantage
  
  

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)
  

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 career@itm-radiopharma.com.

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.