Experience

Oxurion NV

• Belgium
• Biotechnology Research
• 1 - 100 Employee

• Global Head of QA/QP

  • Oct 2017 - Present



UCB

• Belgium
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Director GMP Corporate QA

  • Feb 2017 - Sep 2017



Baxter International Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Director QA IV Therapy

  • Apr 2011 - Jan 2017

  • Managing all activities for 55+ QA employees in a Global Medical Products Quality organization, serving both Manufacturing and R&D as follows:- Managing global QA teams based in US, China, Italy, Sweden and Belgium- Primary focus is on sterile IV solutions/devices and parenteral nutritional products, anesthesia , oncology and biological/biosurgery products in the areas of Design Control, Change Control, CAPA, Risk Management, Field Corrective Actions, and Complaint Investigations.- Provide frontline Quality support for both New Product Development and commercial Drug Products- Maintain site quality compliance by leading regulatory MoH inspections/pre-approval inspections (FDA, Belgian MoH) and Notified Body medical device (TÜV) audits- Implementing and execution of the Quality Systems for US, Belgium, China and India Baxter R&D centers



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• •Associate Director GMP QA R&D

  • 1996 - Mar 2011

  • GMP QA R&D responsible for R&D Supply Management- Deviation and CAPA management- Complaint management- SOP management.- Inspection support (FDA, EMEA and client audits)- Coordination of the monthly and quarterly Quality Review Meetings• Fulfilling the duties of a Qualified Person as described in the applicable European and Belgian legislation for Investigational Medicinal Products.• Managing global teams (US, Europe and India) for implementing Global Quality Standards within the R&D organization