Experience

SGS Life Science Services, S.A.

• Belgium
• 1 - 100 Employee

• Quality Compliance Manager

  • Jan 2020 - Present



Iris

• Facilities Services
• 100 - 200 Employee

• Quality & Procurement Mgr

  • Mar 2019 - Dec 2019



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• QA Manager Benelux - Country Quality Specialist

  • Jan 2016 - Dec 2018

• Country Quality Specialist / Global Safety Manager

  • Apr 2015 - Dec 2015

  CQS for 50% combined with 50% Global Safety Manager (Maternity leave replacement). Responsibilities include training of both staff, patient support programs, and of the out of office hours call center. Adverse event intake and periodic/ ad hoc reporting responsibilities.

• Compliance Manager / Country Quality Specialist

  • Apr 2013 - Mar 2015

  A combined role of healthcare compliance (which included monitoring on processes in business units, Data Privacy Officer, implementing and training of new procedures) and Quality within the Belgian affiliate (which included quality management system oversight for Belux, product complaint handling, mock recall, and recall coordination).

• Senior Associate Regulatory Affairs and Compliance

  • Jun 2012 - Mar 2013

  Replacement of the regulatory affairs and compliance manager (who was on maternity leave). Responsibilities in regulatory affairs aspects of the Belgian affiliate (submission of variation dossiers, review of commercial artwork, liaising with relevant competent authorities), Regulatory Liaison for South Africa (coordination of submission of clinical trial applications and question handling, review of site initiation packages, coordination of clinical labelling requirements. Responsibilities in compliance aspects of the Belgian affiliate. Show less



OIVO-CRIOC (Research & Information Centre of the Consumer Organisations)

• Brussels Area, Belgium

• Research Director

  • Nov 2009 - Nov 2011

  Line-management; Project management of federal and European projects on several different topics (e.g. Child safety, consumer education, durable consumption, and food wastage). Member of SALV (Strategic advisory board of agriculture and fishery); Patientplatform at FAMHP (Federal Agency of Medicines and Health Products); …. Line-management; Project management of federal and European projects on several different topics (e.g. Child safety, consumer education, durable consumption, and food wastage). Member of SALV (Strategic advisory board of agriculture and fishery); Patientplatform at FAMHP (Federal Agency of Medicines and Health Products); ….



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Clinical Research Associate

  • Nov 2007 - Oct 2009

  NV Roche SA - Phase 4 clinical trials; Merck sharp and Dohme - Phase 1 clinical trials NV Roche SA - Phase 4 clinical trials; Merck sharp and Dohme - Phase 1 clinical trials