Corporate Vice President - Global Quality and EHS. Overall responsible for Quality in LEO globally: GMP, GCP, GLP, GDP, Release of drug product and Investigational Medical Products, QA for Pharmacovigilance, Environment, Health and Safety, Quality systems and IT systems.
Transformed global quality systems (Quality-manual, policies, SOP-system, deviations, recurring deviations, audits, change controls, customer complaints, GCP set-up, validations etc.) into more modern levels - with a pragmatic low cost attitude.
- • Implemented quality IT-systems (document handling system, and system for quality processes) to become more effective and to
support the business
- • Introduced Quality Metric globally which gave much better management overview of the compliance status of the entire company
- • Introduced LEAN in Quality globally which resulted in a more efficient quality organization
- • Introduced Quality Management Reviews according to EU legislation. This gave top management a much better tool for high level decisions
- • Built up an ISO system as Medical Devices were introduced in LEO. ISO certification achieved so LEO could go into the medical devices business
- • A number of comprehensive reorganizations that resulted in a more agile and efficient Quality organization with stakeholder orientation
- • Run a global company-wide compliance programme of 100+ mio € during a number of years to upgrade facilities, systems and documentation to ensure that quality compliance was up to date
- • Ensured the LEO Group globally was transformed to a compliance level with no major troubles with authorities
- • Participated in several filings and succesful launches of new products
- • Worked with transformation of Quality in a development company into a commercial company
Corporate Vice President - Global Quality and EHS. Overall responsible for Quality in LEO globally: GMP, GCP, GLP, GDP, Release of drug product and Investigational Medical Products, QA for Pharmacovigilance, Environment, Health and Safety, Quality systems and IT systems.
Transformed global quality systems (Quality-manual, policies, SOP-system, deviations, recurring deviations, audits, change controls, customer complaints, GCP set-up, validations etc.) into more modern levels - with a pragmatic low cost attitude.
- • Implemented quality IT-systems (document handling system, and system for quality processes) to become more effective and to
support the business
- • Introduced Quality Metric globally which gave much better management overview of the compliance status of the entire company
- • Introduced LEAN in Quality globally which resulted in a more efficient quality organization
- • Introduced Quality Management Reviews according to EU legislation. This gave top management a much better tool for high level decisions
- • Built up an ISO system as Medical Devices were introduced in LEO. ISO certification achieved so LEO could go into the medical devices business
- • A number of comprehensive reorganizations that resulted in a more agile and efficient Quality organization with stakeholder orientation
- • Run a global company-wide compliance programme of 100+ mio € during a number of years to upgrade facilities, systems and documentation to ensure that quality compliance was up to date
- • Ensured the LEO Group globally was transformed to a compliance level with no major troubles with authorities
- • Participated in several filings and succesful launches of new products
- • Worked with transformation of Quality in a development company into a commercial company