Project Leadership of Widler & Schiemann AG

Widler & Schiemann AG is a consultancy that provides our clients with experienced business professionals to deliver effective and productive business solutions. The following list represents just a selection of our projects:

  • Invented, led and shaped the Quality Risk Management strategy, concept and methodology for Clinical Trials and Drug Safety and drove the process and organizational design and implementation.
  • Integration of two Clinical QA departments into a fully operational Quality Management function providing quality risk management and QA oversight to the areas of clinical trials (phases 1 – 4) and Pharmacovigilance including GLP, CSV and vendor quality management aspects.
  • Led the re-engineering of the SOP management system at a large pharmaceutical company and together with a global software company introduced Structured Content Management (SCM) to SOP management in mid-size and start-up companies.
  • Led a Clinical Supply Chain optimization project on a global scale based on quality, compliance and operational risk management approach in order to consolidate the IMP processes after a merger.
  • Led the team for the analysis of an R&D strategy and organizational set up of a small US Biotech company including development of a restructuring plan and recommendations for a strategy shift.
  • Led Task Force for QA- & GCP- integration of the Japanese subsidiary development operations of a global pharmaceutical company.
  • Co-ordination, organization of and strategic guidance for more than 50 FDA, EMA, JPMA initiated inspections globally.
  • Developed, led and implemented the strategy for off-shoring all transactional disclosure activities to a third-party service provider to drive quality and optimize costs.
  • Performed more than 100 audits worldwide (e.g. Europe, Eastern Europe, US, Latin-American, Japan, Australia and China).
  • Provided strategic GCP & compliance guidance to senior management, clinical teams & NGOs.
  • Re-engineered and implemented a new process for packaging and labeling of IMPs at a major pharmaceutical company.
  • Developed and implemented a cleaning validation concept and process design at a pharmaceutical trade packaging plant.
  • Co-developed an ERP module with a software provider for the support of a global Clinical Supply Chain.
  • Performed numerous key organizational analyses including R&D, Manufacturing and IT processes.
  • Various reengineering assignments in Health Care along the entire value chain including implementation.
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