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Associate Director Audits and Inspections (100%)

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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.

The Associate Director Audits and Inspections is responsible for managing the inspection and supplier qualification processes. With working place in Thörishaus (Berne) we want to strengthen our Quality team with a

Associate Director Audits and Inspections (100%)

Main responsibilities:

  • Management of the self-inspection program at the site
  • Management of Health Authority inspections
  • Supplier qualification
  • Management of audit and inspection related Deviations, CAPA and Change Control
  • Ensures that the allocated quality-systems are compliant with regulatory expectations
  • Continuously improves the allocated quality systems

Qualification requirements:

  • Minimum of Master of Science (MS) required in scientific field
  • Minimum of 5 years relevant experience in a GxP regulated pharmaceutical/biotechnology industry
  • Profound knowledge of pharmaceutical regulations
  • Strong background in performance of audits and inspections, certification as auditor is a plus
  • Solid computer skills including MS Office
  • Analytical thinking and problem-solving attitude
  • Multilingual – at least German and English, written and spoken
  • Willingness to travel up to 50% of the working time

Please use for your application the following link: https://paxvax.bamboohr.com/jobs/view.php?id=233

Adresse

Emergent BioSolutions Berna GmbH
Daniel Mauron
Director Human Resources
Oberriedstrasse 68
3174 Thörishaus
+41 31 8885225

Website https://www.emergentbiosolutions.com/

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