Experience

QUESTALPHA GmbH & Co. KG

• Germany
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Executive Quality Management Representative

  • Jan 2021 - Present

  Person Responsible for Regulatory Compliance (MDR) Person Responsible for Regulatory Compliance (MDR)



Kettenbach GmbH & Co. KG

• Germany
• Medical Equipment Manufacturing
• 1 - 100 Employee

• VP Quality and Regulatory

  • Apr 2019 - Present

  Person Responsible for Regulatory Compliance (MDR) Authorized Quality Management Representative Person Responsible for Regulatory Compliance (MDR) Authorized Quality Management Representative



Abbott Diagnostics Business

• Director Quality Assurance (Quality Site Head)

  • May 2017 - Mar 2019

  Quality Management Representative at largest IVD manufacturing site of the Abbott Diagnostics Division. The Wiesbaden (Germany) site has >1500 employees. Worldwide registration (inkl. USA). Quality Management Representative at largest IVD manufacturing site of the Abbott Diagnostics Division. The Wiesbaden (Germany) site has >1500 employees. Worldwide registration (inkl. USA).



Alcon, A Novartis Division

• Head of QC

  • May 2013 - Apr 2017

  Functional lead of QC and AS&T unit, including analytical, microbiology & monitoring, packaging packaging materials. Functional lead of QC and AS&T unit, including analytical, microbiology & monitoring, packaging packaging materials.



Novartis Vaccines and Diagnostics

• Switzerland
• Pharmaceutical Manufacturing

• Head of QC Chemistry

  • Jun 2009 - Apr 2013

  Functional lead of analytical QC (Incoming Inspection, Analytical, Biochemistry, Immunology, Stability and LIMS)80 FTE, 5 Mio€ budget

• Deputy head of Technology Development

  • Apr 2006 - May 2009

  Development of cell culture derived influenza vaccine. Registration in Europe and US.



Chiron Corporation

• United States
• Biotechnology
• 100 - 200 Employee

• Manager Process development

  • Aug 2001 - Mar 2006

  Development of immunological methods (e.g. ELISA) for the quantification of viral proteins (Influenza, HIV, HCV, SARS) Development of immunological methods (e.g. ELISA) for the quantification of viral proteins (Influenza, HIV, HCV, SARS)