Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life. As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats. We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.
At Emergent Biosolutions Bern, the Swiss affiliate there are - beside manufacturing activities – professionals in Quality Assurance and – Control, Supply Chain and Regulatory affairs working. We are heading to the next period of growth with more than 100 professionals working on the Swiss site of Emergent in Bern / Thörishaus.
With working place in Thörishaus (Berne) we want to strengthen our Quality Assurance team with a
Manager QA Operations (100%)
The Manager Quality Assurance Operations is responsible for managing compliance of quality systems processes.
Responsible for the management of Deviations, Changes, CAPAs and Complaints
Performs Batch Records Review and the preparation for the Batch Release
Ensures that the allocated quality-systems are compliant with regulatory expectations
Establishes quality procedures within the area of responsibility
Continuously improves the allocated quality systems
Participates in audits and inspection within the area of responsibility
Minimum of Master of Science (MS) required in scientific field.
Minimum of 3 years relevant experience in a GxP regulated pharmaceutical/biotechnology industry.
Batch Records Review and Batch Release experience required
Solid computer skills including MS Office required.
Analytical thinking and problem-solving attitude
Multilingual – at least German and English, written and spoken.