CatalYm GmbH is a well-funded, clinical-stage biotechnology company focused on revolutionizing cancer treatment through the development of Visugromab, an innovative immunotherapy designed for patients with advanced solid tumors. Visugromab targets the immunosuppressive cytokine GDF-15, which is markedly overexpressed across various tumor types. This novel approach has demonstrated the ability to reinvigorate anti-tumor immune responses and produce clinically significant outcomes in patients previously unresponsive to immunotherapy. Building upon highly promising results from Phase 2 clinical trials, Visugromab is now poised to advance through mid-stage to late-stage clinical development. As we remain steadfast in our commitment to bringing this therapy to patients in need, we are seeking a dedicated Quality Assurance Manager to join our team and contribute to its successful progression.
Quality Assurance Manager (m/f/d)
Your responsibilities include:
- Maintenance, upkeep, and further development of the internal quality management system (QMS)
- Creation, maintenance and review of department-relevant SOPs and forms
- Support in 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
Who you are:
- Completed scientific/medical/pharmaceutical studies or training as an MTA/PTA or similar
- 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 planning, implementation and evaluation of internal audits in a GCP regulated environment
- Organizational talent and a structured, independent way of working
- teamoriented
- strong hands-on mentality
- Proficient computer skills (excellent knowledge level of MS Excel and MS PowerPoint) and fluent in English with excellent oral and written skills; good level of German.
We offer:
- 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
The position is located at the Innovations- und Gründerzentrum Biotechnologie (IZB) in Martinsried.
Applications for this position should be uploaded via the online system and include a cover letter indicating Job ID CAT-AS, your CV, and references as well as salary expectations.
We use the “Recruiter on Demand” service by Constares. A Constares Consultant is managing this position. For further questions, please reach out to Tom Schwarzbach via
email.