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!

Quality Assurance Manager (f/m/d)

Festanstellung, Vollzeit · Planegg-Martinsried

Your tasks and responsibilities:

As a Quality Assurance Manager at CatalYm, you will play a crucial role in ensuring the highest standards of quality and compliance in our clinical development programs. You will be a key driver in maintaining and improving our Quality Management System (QMS) and ensuring inspection readiness. Your responsibilities will include:

Developing and Optimizing Quality Management Systems: support the development, maintenance and continuous improvement of Standard Operating Procedures, Working Instructions, Forms.
Audits: Contribute to the establishment and execution of the yearly audit plans including supervision of CAPA completion and effectiveness checks; Support auditor selection, contracting, and audit execution.
Clinical Trial oversight / Inspection readiness: Collaborate with clinical development teams to ensure robust trial oversight, vendor management, and inspection readiness.
Regulatory Inspections: support preparation and hosting of regulatory authority inspections
Clinical Risk Management: contribute / support clinical Risk Management and the development of risk mitigation strategies.
Training & Knowledge Management: Develop and execute training plans, conduct onboarding training and refresher sessions, develop and maintain training documentation system
Quality-related inquiries: organize and supervise QA mailbox, process inquiries within QA Team and ensure timely replies (either reply as Subject Matter Expert (SME) or contribute to elaboration of reply), participate in selected trial team meetings as SME
QA filing and archiving system: ensure state-of-the-art QA filing and archiving systems, serving as an expert for Trial Master File (TMF) processes.

Your profile:

Education and Experience Requirements:

Degree in natural science (B.Sc and above) or comparable qualification
Demonstrated knowledge of ICH GCP, global regulations and guidelines applicable for the conduct of clinical trials
3-5 years of experience in Quality Management in a GCP-regulated environment within the pharma/biotech industry
Several years of experience in conducting clinical trials according to ICH GCP
Knowledge in the planning, implementation and evaluation of audits in a GCP regulated environment

Skills and Competencies:

Strong analytical, problem-solving, and decision-making abilities
Well-organized with a structured and independent working style
Proactive, hands-on mentality with a team-oriented mindset.
Very good command in English
MS Office skills are required

Why us?

Impact & Growth - Be part of a dynamic, goal-oriented company where your contributions truly make a difference.
Innovation - Work on groundbreaking immuno-oncology therapies with a mission-driven team.
Collaboration & Culture - Enjoy a multicultural, open, and appreciative work environment and direct communication channels.
Additional Benefits - Competitive compensation, professional development opportunities, and more!

Join us in shaping the future of cancer therapy!

Apply now

Full-Time , Permanent

Specialist

Updated at 04/11/2025

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