Team Lead QA Module o
vor 1 Monat
Switzerland, VispToday, 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.
The **QA Team Leader Module O & R** is directly involved in project work as Quality Assurance and also leads a middle sized team of QA Manager (various scope) which requires coordination and assignments of actions/task to the team.
Key Responsibilities:
- Responsible for project specific QA work of GMP products manufactured in PCP & PCPSS and MC1, in particular:
- Control and approval of master manufacturing protocols, check for consistency with regulatory documents (BLA, NDA, CMC, DMF etc), process descriptions, test plans, parameter lists etc.
- Control of completed batch documentation
- Assessment and approval of change requests
- Control and assessment of deviations, decision if the investigation meets GMP requirements
- Release of deviations based on the escalation principle according to current procedures
- Leading the QA team "QA-Group Module O & R" within "QA BioConjugates"
- Maintenance of customer contacts
Key Requirements:
- Completed technical or university education in life science (microbiology, biotechnology, chemistry, biology, biochemistry etc.)
- Substantial experience in the area of cGMP related biopharmaceutical manufacturing, preferably within a Quality Unit and project and team management functions
- First experience in people management and lead of middle sized teams
- experience in interaction with all kind of interfaces within the organizations (including external companies) and with regulatory agencies (Swissmedic, FDA etc.)
- Excellent German and English skills (written and spoken)
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: R53016**:
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