Quality Manager (All genders | Full time | Fixed 6 to 12 months contract)

IRUBIS GmbH is a life science tools startup that pioneers real-time bioprocess analytics with mid-infrared (MIR) spectroscopy. Our mission is to revolutionize bioprocess monitoring and control with innovative and user-friendly tools, enabling the next generation of biopharmaceutical production. To support our growth and meet the high standards of our clients, we are building a Quality Management System according to ISO 9001 and ensuring GMP readiness.TasksEstablishing and implementing an ISO 9001-compliant QMSEnsuring GMP requirements (esp. data integrity, documentation, software validation)Creating, maintaining, and training quality processes, SOPs, and manualsPreparing and supporting internal and external auditsSetting up processes for CAPA, deviations, change control, and supplier managementCollaborating closely with internal teams (R&D, Production, Service) and external partnersRequirementsProven track record in developing and implementing ISO 9001-compliant QMSSolid expertise in GMP environments (pharma, biotech, medtech, or suppliers)Familiar with Annex 11 / 21 CFR Part 11, CSV/CSA approaches, and data integrity (ALCOA+)Hands-on experience with audits and certification processesPragmatic, structured approach and ability to drive solutions efficientlyStrong communication skills in German and EnglishBenefitsModern office space: centrally located in MunichFlexible working hours, a great team and flat hierarchiesExciting personal development opportunitiesStay fit and energized with EGYM Wellpass access, fruit basket and refreshing drinksCompany events: enjoy summer parties, traditional Wiesn visits, and our annual Christmas celebration!Does it all sound interesting to you? Then send us your curriculum vitae without a personal photo in a PDF document.Location: Bayerstraße 85a, 80335 MunichStart time: Flexible