Your mission

• Maintenance and further development of the internal Quality Management System (QMS)
• Creation, maintenance and review of department-relevant SOPs and forms
• Supporting the planning and implementation of internal audits as part of GCP quality assurance (protocol, PI, CRF, final reports) in the form of TMF audits and/or internal system audits
• Conducting training courses for employees on the QMS and training new employees 
• Responsible for Corrective and Preventive Action (CAPA) Management at CatalYm
• Central contact person for all internal and external quality-related issues
• Support and processing of inquiries and qualification questionnaires as well as contracts

Your profile

• Completed scientific/medical/pharmaceutical studies or training as MTA/PTA/ or medical documentalist
• 3-5 years of experience in quality management in a GCP-regulated environment
• Several years of experience in clinical studies according to ICH-GCP
• Knowledge in the planning, implementation and evaluation of internal audits in a GCP regulated environment
• Organizational talent with a structured, independent way of working
• Teamoriented
• Strong hands-on mentality
• Very good English and MS Office skills are required

Why us?

• Room for independent working in X-functional teams
• Direct and quick internal communication channels
• Dynamic and goal-orientated environment
• Open and appreciative corporate culture in a multicultural environment
• Home office possible in coordination with the team assistant
• Part-time position possible (min 30 h)
• Several benefits: kindergarten / travel allowance etc 

About us

CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!