Quality Assurance manager
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 DP focused branch located in Basel, Switzerland 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 this new role as a Quality Assurance manager.
Establishing and maintain contact with the relevant stakeholders at Lonza’s manufacturing sites worldwide
Oversight and documentation of Lonza Sales AG’s trading activities including confirmation of compliance with FAMI QS and GDP (Good Distribution Practices) requirements
Establishing monthly reports on traded goods as well as Annual Product Reviews (APQRs) and Management Review reports
Following up with the different sites any corrective actions needed
Prepare the monthly Quality Councils for Lonza Sales AG
In collaboration with Lonza AG’s experts, develop and implement IT solutions to allow better oversight of site specific documentation
Together with the Responsible Person (FvP) of Lonza Sales AG further develop the Quality Management Systems (QMS)
Maintaining a compliant and efficient QMS
Ensure inspection readiness for Lonza Sales AG
Supporting the Responsible Person (FvP) of Lonza Sales AG during regulatory inspections
Ph.D. or Master's degree in chemistry, biotechnology, life science or related field
Extensive experience in the pharmaceutical industry; preferable in a QA role or actively involved in GMP manufacturing
Understanding of the applicable cGMP regulations, especially GDP
Competent level of general IT skill is required
Auditing experience, auditor certification is an asset
Ability to oversee project execution to identify non-compliance from quality standards
Able to work autonomously with and to develop procedures if required
Excellent verbal, written and interpersonal communications skills
Fluency in English is mandatory German will be very positive to have
Excellent organizational skills
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.