Global Head Sterility Assurance

Switzerland, Basel

Today, Lonza is a global leader in life sciences operating across three continents. 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 are looking for a strong Quality Network Head (f/m/d) to support the growing Drug Product Services organization across the Lonza sites.

Key responsibilities:

  • Developing, implementing and continuously improving biological (viral, bacterial, fungal, mycoplasma, and other adventitious agents) contamination control strategies for sterile drug product manufacturing

  • Drives and oversees global sterility assurance strategy, risk assessment, mitigation definition and gap closure and sustainable implementation in close collaboration with all sites and their Sterility Assurance Leads

  • Responsible to assist sites in response to adverse trends or contamination events with root cause analysis and global implementation of preventive actions where appropriate

  • Supports coaching and training of employees at manufacturing sites to improve understanding of biological risks and aseptic practices

  • Improves standardized procedures across the network for microbiological and segregation control aspects of facility and equipment design, process design, material transfer, maintenance, training, sampling, testing, and cleaning / disinfection.

  • Responsible global expert to implement phase appropriate sterility assurance practices as part of the new product introduction process

  • Supporting microbiological control and sterility assurance across the global network, covering sites with manufacturing of sterile drug substance and drug product

Key requirements:

  • Bachelor’s Degree in a Life Sciences, Engineering or Quality Management or related science discipline

  • English

  • Strong leadership experience, influencing skills, business acumen & proven track record of developing a strong team

  • CDMO experience preferred

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: R36242