Quality Assurance Manager Environmental Monitoring (EM) 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 Quality Assurance Manager – Environmental Monitoring, Ibex™. As a member of the QA department, you will be responsible to ensure that all processes for facilities, equipment, utilities and systems with regards to environmental monitoring (EM) qualification complies with cGMP requirements and internal/external quality standards over the entire life cycle. As a quality and compliance representative, will also acts as a key member in the cross-functional technical project teams

Key responsibilities:

  • Own all Quality and Compliance related responsibilities for the qualification and routine monitoring of the facility and utilities
  • Coordinate Quality and Compliance objectives during the different project phases (e.g. zone concept, process, cleaning, Environmental Monitoring (EM), etc.)
  • Identify emerging QA relevant topics, communicate to the Ibex™ QA organization (e.g. new technologies) and work actively on their development into new or already established Quality and Compliance strategies and/or standards
  • Review and approve Qualification Documents (e.g. Performance Qualification (PQ) Plan and Reports, etc.)
  • Act as decision-maker if new or changed QA strategies or standards are identified
  • Review and approve technical change requests during the different phases of a project and assess their relevance to the qualification of the facility, utilities and systems
  • Ensure investigations and deviations are appropriately investigated and documented
  • Responsible to drive CAPA (Corrective And Preventive Actions) and Effectiveness Check items to completion and timely closure
  • Approve EM Reports, Risk Assessments and sampling plans for Environmental Monitoring of clean rooms/utilities and assess results during PQ
  • Support and approve quality risk analysis, e.g. Failure Mode and Effects Analysis (FMEA)
  • Represent EM topics during internal/customer audits and regulatory inspections
  • Write or revise SOPs in your area of SME and act as owner of such documents

Key requirements:

  • Bachelor, Master Degree or PhD in Biotechnology, Pharmacy, Microbiology, Chemistry, Engineering, or related field
  • Significant experience in the area of biopharmaceutical manufacturing in an EM function
  • Strong background in cGMPs
  • Broad knowledge of engineering and manufacturing processes
  • Good communication skills and interaction with all kind of interfaces within the organization and with Health Authorities (Swissmedic, FDA etc.)
  • Sound experience in representing Quality and Compliance in projects
  • Strong team orientation
  • Structured, focused and well-organized working attitude
  • Open-minded for new ideas and suggestions
  • Solution-oriented, agile and highly motivated
  • Fluency in German and English

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: R21194