Head of Quality Assurance
vor 1 Tag
Your missionAs 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 areasExploring the needs for a transition to an electronic QMS solution and driving the decision making processDevelop 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 areasEnsure inspection readiness across all departments governed by GMP and GCPServe as a member of the Development Leadership Team or Product Lifecycle Team, providing quality input to CMC, regulatory, and clinical operations decisionsEstablish a phase-appropriate QMS suitable for a small biotech environment with outsourced manufacturingBuild a quality culture emphasizing transparency, continuous improvement, and accountabilityYour profileAdvanced 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 ComplianceA clinical development background is required Experience in preparing for and managing regulatory inspections Comprehensive knowledge of global GxP regulations, with main expertise in GCPStrong leadership skills with the ability to work in a matrix settingExcellent 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 basisWhy 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 weekAbout usCatalYm 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
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Quality Assurance Internship
vor 2 Wochen
Planegg, Deutschland Planet A Foods GmbH Vollzeit**Do you want to make a delicious difference?**: As our Quality Assurance Intern you will support the Quality Team by maintaining and auditing documentation across functions, screening and identifying gaps in supplier records, and assisting in risk evaluation to uphold quality standards. **A Taste of What to Expect**: - ** Maintaining Documentations Across...
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Teamleiter Quality Assurance
Vor 2 Tagen
Planegg, Bayern, Deutschland CompuGroup Medical Vollzeit 80.000 € - 120.000 € pro JahrAls führendes Unternehmen im Bereich Softwarelösungen für das Gesundheitswesen sind wir in 19 Ländern tätig und beschäftigen über 9.000 engagierte Mitarbeitende. Du wirst in einem dynamischen und innovativen Umfeld arbeiten, das voller Möglichkeiten steckt. Mit Deinem Einsatz und Deiner Leidenschaft hast Du die Gelegenheit, einen nachhaltigen...
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Head of Project Management
vor 2 Wochen
Planegg, Bayern, Deutschland Proteros Biostructures GmbH Vollzeit 80.000 € - 120.000 € pro JahrYour missionWe are looking for an experienced and inspiring Head of Project Management (gn) to lead, develop, and optimize the overall project management organization at Proteros. In this key leadership role, you will manage the entire project portfolio across business units, align project delivery with strategic goals, and ensure seamless communication...
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Head of Procurement
vor 2 Wochen
Planegg, Deutschland Planet A Foods GmbH Vollzeit**Your mission**: At Planet A Foods, we are revolutionizing the food industry to protect the planet we love. by perfecting centuries-old fermentation technology, we offer healthier alternatives and can save up to 500 Mt of CO2 per year! We created the world’s first 100% cocoa-free chocolate called ChoViva. Our ChoViva tastes amazing with a solid snap and...
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Head of People
vor 1 Woche
Planegg, Deutschland Planet A Foods GmbH VollzeitDo you want to make a delicious difference?Planet A Foods is for those who want to build something extraordinary with tangible purpose.We’re reinventing how the world makes food ingredients, such as chocolate, replacing scarce, unsustainable raw materials with scalable, clean, and delicious alternatives.We are united by impact, driven by innovation, and...
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Head of People
Vor 6 Tagen
Planegg, Deutschland Planet A Foods GmbH Vollzeit**Your mission**: Are you passionate about leading a dynamic team and fostering an extraordinary company culture? Join Planet A Foods as our **Head of People & Culture**! Our mission is to revolutionize the food industry and protect the planet we love! We believe perfecting centuries-old fermentation technology leads to healthier food alternatives and can...
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Head of People
vor 2 Wochen
Planegg, Deutschland Planet A Foods GmbH VollzeitDo you want to make a delicious difference?Planet A Foods is for those who want to build something extraordinary with tangible purpose.At Planet A Foods, we’re reinventing how the world makes chocolate and other food ingredients replacing scarce, unsustainable raw materials with scalable, clean, and delicious alternatives.We are united by impact, driven by...
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Head of Grants Office
vor 2 Wochen
Planegg, Deutschland Max-Planck-Institut für Biochemie VollzeitJob DescriptionThe Max-Planck-Institute of Biochemistry (MPIB) in Martinsried near Munich is one of the world's leading international research institutions in the fields of biochemistry, cell and structural biology, and biomedical research. With around 27 scientific departments and research groups and about 750 employees, the MPIB is one of the largest...
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Head of Grants Office
vor 3 Wochen
Planegg, Deutschland Max-Planck-Institut für Biochemie (MPIB) VollzeitHead of Grants Office (m/f/d) Full-time The Grants Office supports researchers at the Max-Planck-Institute of Biochemistry and the Max-Planck-Institute for Biological Intelligence in securing and managing third-party funding. As a scientific service unit, it oversees a portfolio of over 30 projects with a total value exceeding EUR40 million, with strong...
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Head of Grants Office
vor 3 Wochen
Planegg, Deutschland Max-Planck-Institut für Biochemie VollzeitHead of Grants Office (m/f/d) Full-time The Grants Office supports researchers at the Max-Planck-Institute of Biochemistry and the Max-Planck-Institute for Biological Intelligence in securing and managing third-party funding. As a scientific service unit, it oversees a portfolio of over 30 projects with a total value exceeding EUR40 million, with strong...
