Carsten Bierans

Experience

• 

  Werum

  Jun 1997 - Dec 2003

  Project Manager

  Organization, preparation and monitoring of all software development life cycle activities (planning, specification, development, verification, reporting)

• 

  Körber Pharma

  Dec 2003 - now

  - Responsibility for the global ISO9001 certified quality management system (Germany, EU, USA, Asia)- Establishment and management of the QM team with 15 employees at locations in Germany and the USA- Involvement of more than 100 vendor audits executed by considerable companies of the pharmaceutical and biotechnology industry- Certification of ISO9001 quality management system- Identification of potentials for improvements, definition and tracing of actions for process enhancements and efficiency increase, i.e. as a Lean Six Sigma Silver Belt- Definition and surveillance of standardized processes of (agile) software development lifecycles according GAMP5- Development of a supplier quality management program- Consulting for validation of computerized system- Compliance and Data Integrity consulting (functional fulfillment of regulatory requirements in the software) according to international Good Manufacturing Practice regulations- Collaboration in global projects and multinational teams- Member of internal Idea Management Team for new digitization products Show less

  • Vice President Quality Management Software

    Jul 2021 - now

  • Vice President Quality Management

    Sept 2020 - Jun 2021

  • Senior Head of Quality Management

    Jan 2012 - Sept 2020

  • Senior Quality Manager

    Dec 2003 - Dec 2011