Team Lead QA Oversight Manufacturing (80 - 100%)
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.
For Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Team Lead QA Oversight Manufacturing.
Lead and manage a team of experts and develop them and deputize Head QA Manufacturing as required
Execute establishment and maintenance of the Quality Oversight (Shop floor QA) at DPS Manufacturing (aseptic manufacturing, process simulations (APS), environmental sampling, proper qualification of DPS staff in aseptic techniques)
Oversee material qualification/storage/transport and material/personnel flow according to GMP regulations and assure Vendor Supply Chain Integrity
Perform technical release/rejection for incoming material (e.g. Excipients, Drug Substance, Primary Packaging Material and Consumables) as well as APS in delegation from qualified person (FvP)
Ensure corresponding elements of the corporate Lonza GMP Quality Manual are appropriately implemented and followed
Consult line functions concerning product and process related topics.
Approve change requests, deviation and CAPAs related to product and process
Promote and enforce compliance to internal and external guidelines regarding quality and safety
Academic degree (Master or higher) in Natural Sciences, Pharmaceutical Sciences or related field
Extensive working experience in Quality Assurance in pharmaceutical industry and GMP environment
First experience in a direct Leadership role is required
Profound knowledge in aseptic manufacturing of chemical and biological drug products
Sound knowledge of written and spoken German and English is required, French is of advantage
Shop-Floor QA experience is an advantage
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.