HBX PHARMA
Quality Manager / Qualified Person / Responsible Person
About Me
I am a freelance Industrial Pharmacist with 18 years experience in the Human and Veterinary Pharmaceutical and Medical Devices Industry. During my career I have successfully led companies to their GMP, GDP and ISO 13485 certification, and have supported them as a Qualified Person and Responsible Person. My specialty is Quality Assurance, offering tailored solutions for Regulatory and Compliance Requirements.
Work Experience
Download my curriculum vitae or connect with me on LinkedIn
Most relevant
STERIMA
Head of QA/QC/RA TeamSTERIMA
Head of QA/QC/RA Team
01/2022 – 07/2025
Kortrijk, Belgium
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Managing the quality team at Sterima (4 direct reports) across two manufacturing plants
- Quality Representative in the Leadership Team
- Sterilization of Medical Devices
- ISO 13485 certification of the Quality Management System
-
CE certification of a new Medical Device, in line with the Medical Device Regulation (MDR)
PFIZER
Qualified Person and Responsible PersonPFIZER
Qualified Person and Responsible Person
06/2025 – 01/2020
Brussels, Belgium
Qualified Person and Responsible Person:
- EU batch release
- Administrative release according to GDP guidelines
- Maintenance of the Quality Management System
- Inspection readiness exercise for FAGG audit
- Deviation handling
Managing of compliance at Contract Manufacturing Organizations (CMOs):
- Regulatory compliance of registration dossiers
- Complaint handling
- Change controls
ELANCO ANIMAL HEALTH
Responsible Person and Quality Assurance ManagerELANCO ANIMAL HEALTH
Responsible Person and Quality Assurance Manager
02/2020 – 12/2021
Antwerp, Belgium
- Quality Manager for the Benelux and Nordics Affiliate regions, leading a team of two people
- Responsible Person for Elanco Belgium and Elanco Netherlands
- Obtaining two Wholesale Distributor Authorisations (WDA) and two Feed Licenses under strict time pressure
BOEHRINGER INGELHEIM
Quality Assurance ManagerBOEHRINGER INGELHEIM
Quality Assurance Manager
03/2014-04/2015
Brussels, Belgium
- Improvement of GDP compliance
- Audit of Third Party Logistical suppliers
- GDP batch disposition
- Quality representative for GAMP5SAP implementation
“Thank you for your continued support to Operations and providing clear explanation when needed.”
“Thanks a lot for getting us through the GDP journey.”
“Thank you for supporting us so well, and for the very pleasant collaboration.”
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Address
HBX BV
VAT BE 0667.649.515
Tulpenstraat 2
9920 Lievegem
East-Flanders, Belgium