Managing Director & Consultant

Action-oriented consultant with solid, many years of experience in quality management & operational excellence in the sectors: pharmacies, medical device manufacturers and pharmaceutical industry

• communicative

• leadership skills

• responsible

• quick learner & problem solver

• results-oriented

• resilient

• flexible

• strong communicator and doer with courage to establish positive changes

• project management and interim management including team leadership in quality assurance

• consulting and stakeholder support

• build and maintain a quality management system

• deviation and change management

• creation of ISO and GMP compliant documents

• planning, qualification and maintenance of clean rooms including routine monitoring with microbiological and particle monitoring

• risk assessment according to ISO 14971 and ICH Q9

• validation of computerized systems

• planning and conducting supplier audits as lead auditor including contract manufacturing management

• support during inspections by authorities and notified bodies

• training and coaching

• batch release and BMR

• development and implementation of quality key figures

• project leadership

• team leadership

• consulting

• process optimization

• lean management

• clean room planning and qualification

• mindset and behavior coach

• ISO 9001 certification