Quality Assurance Manager for Cleaning Validation

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.

We have recently been confirmed as the global manufacturing partner for Moderna’s vaccine against the novel coronavirus, providing a tenfold manufacturing capacity increase. As other businesses face increasing economic uncertainty, we are fortunate to have opportunities for expansion. Through this new collaboration, our work will have a significant, direct and long-term impact on the management of this global pandemic. Become part of this exciting opportunity and join our team by applying for the position as Quality Assurance Manager for Cleaning Validaiton.

Key responsibilities:

  • Ensure QA oversight for site Cleaning Validation activities including cleaning verification, validation activities at small and manufacturing scale, continued cleaning verification and periodical cleaning reviews
  • Act as key member in cross-functional technical project teams and support the site as subject matter expert during inspections by authorities or customer audits
  • Ensure the continuous implementation of the regulatory requirements and Lonza global policies in the laboratories in Ibex Visp
  • Preparation of validation documents in collaboration with the cleaning teams (study design / protocols and reports) according to Lonza procedure and in compliance with regulatory guidance
  • Technical lead of cleaning validation teams including communication with customers, as appropriate
  • Support / review / approve QC cleaning studies
  • Responsible for the cleaning validation assessment by change requests and deviations
  • Maintenance of the cleaning validation matrix to ensure a cleaning validation overview of the plants and the corresponding products
  • Preparation of periodical cleaning review reports with focus on the summary of relevant issues, identification of potential trends/deficiencies to implement CAPAs and a final validation assessment

Key requirements:

  • Bachelor, Master degree or PhD in Analytical Sciences or related field
  • Significant experience in the GMP regulated pharmaceutical industry; preferable in a Quality Unit (QA  or QC)
  • Strong background in cGMP regulations
  • Broad knowledge in cleaning validation of biopharmaceuticals
  • Sound experience in representing Quality and Compliance in projects
  • Experience in interaction with all kind of interfaces within the organization and with regulatory agencies (Swissmedic, FDA etc.)
  • Experienced in the interaction with health authorities (Swissmedic, FDA etc.)
  • Strong team- and solution-orientation
  • Ability to oversee project execution to identify non-compliance from quality standards
  • Ability to prioritize and manage work to critical project timelines in a fast-paced environment
  • Structured, focused and well-organized working attitude
  • Open-minded for new ideas and suggestions
  • Agile, highly motivated and dynamic drive
  • Excellent verbal, written and interpersonal communication skills
  • Fluency in English, German would be an asset

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

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: R23833