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.

Tasks

• Establishing and implementing an ISO 9001-compliant QMS
• Ensuring GMP requirements (esp. data integrity, documentation, software validation)
• Creating, maintaining, and training quality processes, SOPs, and manuals
• Preparing and supporting internal and external audits
• Setting up processes for CAPA, deviations, change control, and supplier management
• Collaborating closely with internal teams (R&D, Production, Service) and external partners

Requirements

• Proven track record in developing and implementing ISO 9001-compliant QMS
• Solid 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 processes
• Pragmatic, structured approach and ability to drive solutions efficiently
• Strong communication skills in German and English

Benefits

• Modern office space: centrally located in Munich
• Flexible working hours, a great team and flat hierarchies
• Exciting personal development opportunities
• Stay fit and energized with EGYM Wellpass access, fruit basket and refreshing drinks
• Company 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 Munich

Start time: Flexible

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