Quality Assurance Manager (m/f/d)

• Educational background in Biology, Pharmaceutical or related domain (BSc / MSc or equivalent education in Science)
  
• At least 5 years of experience in Quality Assurance in an In Vitro Diagnostics company or other related industry (Pharmaceutical,
  Biotechnology, Medical) - including 3 years in a management role
  
• Thorough understanding of ISO Norm 13485, the European Directive 98/79/CE and IVDR and the 21CFR820
  
• Strong leadership, people management and coaching skills
  
• Experience with project management, experience in Lean or Six Sigma projects preferred (Certification Lean / 6 σ Green Belt would be a plus)
  
• Manage, lead and coach the Quality Assurance System team
  
• Ensure conformity and application of the Quality Management Systems across the facility
  
• Manage customer audits and regulatory inspections
  
• Drive strategies to continuously improve Quality Management Systems that enable Bio-Rad to efficiently meet customer and regulatory requirements
  
• Collaborate actively with the business partners to develop quality mindset
  
• Monitor the foreseen regulatory evolutions to anticipate new requirements and get set for the future

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