QA Manager Microbial Control Strategy Ibex™

Switzerland, Visp

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

For Ibex™ Solutions, our recently launched unique biological manufacturing and development concept in Visp, Switzerland, we have multiple openings. Become part of this exciting opportunity and join our team by applying for the position as QA Manager Microbial Control Strategy r Ibex™.

Key responsibilities:

  • Ensure that an end-to-end microbial control concept is developed for the biotechnological drug substance manufacturing facilities and is captured in local documents (incl. specifications, SOPs, etc.)
  • Advise Ibex™ on hygiene related topics
  • Support the Quality Oversight on the activities of the Environmental Monitoring and activities related to the assessment of disinfectants from microbiological expertise point of view
  • Act as Quality Expert for Deviation Reports initiated due to exceeding specifications of microbiological tests
  • Write, Review and approve SOPs, deviation reports and change requests associated with the above-mentioned topics
  • Be member of expert committees and represents QA in projects
  • Act as decision-maker if new or changed strategies or standards are identified
  • Support the preparation and follow-up of customer audits and regulatory inspections; act as an expert during audits / inspections presenting aspects related to the microbial control and sterility strategies
  • Support and approve quality risk analysis (e.g. FMEA = Failure Mode and Effects Analysis)
  • Enhance the quality knowledge by following the quality standards and by visiting specific training courses/conferences
  • Support cGMP training programs to ensure staff is trained

Key requirements:

  • Bachelor, Master Degree or PhD in Science, preferably Microbiology
  • Significant experience in the area of biopharmaceutical manufacturing
  • Strong background in cGMP
  • Broad knowledge related to hygiene topics, environmental monitoring, disinfectant testing, microbial control strategies
  • Good communication skills and interaction with all kind of interfaces within the organization and with regulatory agencies
  • Strong team and solution orientation
  • Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions
  • Agile, highly motivated and dynamic drive
  • Sound experience in representing Quality and Compliance in projects
  • Excellent knowledge of written and spoken English, German skills would be an advantage

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R19736