Managing Director & Consultant

Hands-on consultant with solid, many years of experience in quality management & operational excellence in pharmacies, medical device manufacturing, and the pharmaceutical industry

• communicative

• leadership skills

• responsible

• quick understanding & problem-solving skills

• results-oriented

• resilient

• flexible

• strong communicator and implementer with the courage to establish positive change

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

• consulting and stakeholder support

• setting up and maintaining quality management systems

• deviation and change management

• preparing ISO- and GMP-compliant documents

• planning, qualifying, and maintaining cleanrooms including routine microbiological and particle monitoring

• risk assessment according to ISO 14971 and ICH Q9

• validation of computer-based systems

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

• support during inspections by regulatory authorities and notified bodies

• training and coaching

• batch release and BRR

• developing and implementing quality metrics

• project leadership

• team management

• consulting

• process optimization

• lean management

• cleanroom design and qualification

• mindset and behavior coach

• ISO 9001 certification