Your mission
As the Head of Quality Assurance at CatalYm, you will oversee all Quality Assurance activities in clinical development comprising all aspects of GxP governed processes with a main focus on GMP and GCP including Clinical Safety.
This role provides strategic and hands-on oversight across internal operations and external partners (CMOs, CDMOs, and CROs), ensuring product quality, patient safety, and regulatory compliance throughout the product lifecycle
Your tasks and responsibilities
* Lead the QA department and take ownership of the quality management system (QMS) covering all GxP areas
* Exploring the needs for a transition to an electronic QMS solution and driving the decision making process
* Develop risk-based approaches to quality management in the GxP environment
* Develop and maintain the company’s Quality Strategy aligned with corporate goals and regulatory expectations (ICH Q10, EU GMP, 21 CFR 210/211, 600, 820)
* Oversee the planning and execution of internal and external audits across all GxP areas
* Ensure inspection readiness across all departments governed by GMP and GCP
* Serve as a member of the Development Leadership Team or Product Lifecycle Team, providing quality input to CMC, regulatory, and clinical operations decisions
* Establish a phase-appropriate QMS suitable for a small biotech environment with outsourced manufacturing
* Build a quality culture emphasizing transparency, continuous improvement, and accountability
Your profile
* Advanced degree in life sciences, pharmacy or medicine with 10+ years of experience in pharmaceutical/biotech at least 5 years of those in Quality Assurance or Compliance
* A clinical development background is required
* Experience in preparing for and managing regulatory inspections
* Comprehensive knowledge of global GxP regulations, with main expertise in GCP
* Strong leadership skills with the ability to work in a matrix setting
* Excellent analytical and problem-solving skills
* Fluent in English with excellent oral and written skills; good command of German.
* Flexibility for travel on an as needed basis
Why us?
* Contribute directly to the success of cutting-edge oncology programs.
* Be part of an agile, collaborative biotech environment with visible impact.
* Enjoy flexibility, ownership, and professional growth within a supportive culture.
* 1-2 days home office per week
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!