Quality Assurance Manager

vor 6 Monaten

Basel, Schweiz Lonza Vollzeit

Switzerland, BaselToday, 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.

**Key responsibilities**
- 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

**Key Requirements**
- 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.

**Reference: R54235**:

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