·Pragmatic, committed, result-driven, service-oriented, team-oriented, loyal
·Special strength to recognize general requirements and translate them into schematic concepts. Creative and dynamic.
·Good communication skills (successful professor at Montpellier and Tours University in quality assurance, trainer of clinical trial monitors)
·Languages: French (native language), English, good knowledge in German, Dutch and Spanish
MAIN ACHIEVEMENTS
Built-up an IT-workflow for procedures in Clinical Quality with Aventis
Built-up a global quality system (SOPs) from scratch (visual thinking approach) with Actelion
Realisation of an automatic clinical audits reporting system with Pfizer and Actelion
Successful conduct of an EMEA inspection in Clinical Quality with Actelion
Successful teaching at University from 1995 to now
Built-up a teaching program for new incomers and non clinical research specialist with Actelion
Jacques Wodelet
Quality Manager
Sciez - France
| English | French |
Schools attended |
ULB (Pharmacy) |
Since 2006: Merck Serono International S.A. |
Quality Manager
| |
GxP Audit Manager Clinical Compliance. * International GxP Auditor performing GxP audits (GMP,GDP and GCP activities) * Management of QA activities in the affiliates including CAPA follow-up * QA activities for clinical supplies management at affiliates | |
Sector: Health and pharmaceutical |
2002 - 2006 : Hoffmann La Roche |
Pharma Development Clinical Auditor
| |
System and Process Improvement Specialist in Clinical Quality Research. * Define and/or improve Clinical Research Processes with PDCA cycle * Provide full project management service for quality improvement projects. * Implementation of a GCP Tool kit. International Clinical Auditor | |
Sector: Health and pharmaceutical |
2001 - 2002 : Actelion Pharmaceuticals |
Global Quality Manager
| |
Manager Global Clinical Quality * Building the worldwide Quality System and conducting clinical audits worldwide * Building the Training organization | |
Sector: Biotech |
1993 - 2000 : Pfizer Inc. |
Clinical Quality Standards Manager
| |
Team leader European Expert * Member of a working group on Clinical Audits. Management of a team of 8 people * Built-up a IT workflow for procedures in Clinical Quality * Clinical Quality Management Activities | |
Sector: Pharmaceutical |
Interests |
SCUBA DIVING, WALKING |