Quality Project Lead Strategic Growth Investment & Engineering (m/f/d)
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.
In order to support our strategic growth investment in Stein, the Quality SGIE (Strategic Growth Investment & Engineering) team is looking for an experienced quality leader responsible for the Qualification and Validation aspects of our aseptic filling CAPEX projects portfolio.
Responsible for the Compliance, Qualification and Validation related to large CAPEX projects for the phase Ideation, Feasibility, Concept Design and Basic Design and Execution.
Provide Quality oversight and approval of equipment/facility qualification and validation documents as well as associated change controls.
Provide leadership and guidance to staff on qualification/validation issues.
Ensure that decisions are fully supported by global and local Quality and Regulatory
Escalating issues in an open and timely manner and taking leadership for their resolution
Master degree in Biotechnology, Engineering, Pharmacy or other relevant areas
Recognized expert in the area of cGMP, facility design, Qualification, Validation and aseptic filling.
Significant experience in a regulated pharmaceutical industry including engineering, manufacturing, quality assurance, quality control, R&D and/or drug regulatory affairs
Strong leadership skills and ability to communicate internally and externally at higher levels
Structured, organized, proactive and collaborative working attitude
Strong verbal and written communication skills
Fluent in English and German
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.