While Dr. Beat Widler was the Head of the global Clinical Quality function at Roche, he had direct management responsibility (budget, staffing, planning and project management, etc.) for a department of about 200 staff members.

He Built the department from a group of a few auditors into an integrated Quality Management department that supports the entire Pharma Division in all aspect of GCP quality management (QMS). Implemented innovative approaches to QM and ensured that Roche is seen as the leading company in matters of QM and Quality Risk Management.

He also Founded and chaired the Quality Steering Committee of Roche Pharma that has overall QA responsibility across GLP, GMP, GCP and IT QA.

From 2002 to 2006 he gave leadership to the UK headquarters’ Pharma Development organization of about 750 drug development professionals.

He is a member of the Board of DIA and member of the strategic committee of EMPRA, an EU Commission project.

Also he is a founding member of ACRES.

He had more than 100 audits worldwide (e.g. in Europe, Eastern Europe, US, Latin-American, Japan, Australia and China) as lead or co-auditor covering clinical trial center audits, system audits (e.g. as lead auditor laboratories, “drug supplies”, monitoring systems, archiving, CROs, safety systems, study reports, IRBs / IECs, pre-inspections and inspections by FDA, EMA, MHLW and local inspectorates; as coauditor data management, CSV and informatics audits). Interactions with EMA, FDA, Swissmedic, MHLW with regard to QA aspects of submissions.

He initiated and lead the Roche Pharma Clinical Quality Risk Management (C-QRM) project first in collaboration with WCI and now with Booz & Company. C-QRM applies principles of 6-Sigma and FMEA to clinical development activities and pharmacovigilance to build processes allowing early detection of critical errors and implementation of corrective and preventive actions.

He provided leadership to the Roche Ethics and Sustainability working groups as well as to the SOP re-engineering project.