Thermo Fisher Scientific is seeking a Quality Director for their Bourgoin, France site, responsible for leading the Quality organization in a pharmaceutical manufacturing environment. The ideal candidate will possess a French Pharmacist degree and significant experience in quality leadership, regulatory compliance, and operational excellence
Job Summary
This critical leadership role involves full accountability for the Quality Management System, regulatory compliance, and oversight of QA, QC, and laboratory operations at a global CDMO site.
The successful candidate will act as the registered Qualified Person (QP), ensuring compliance with French, EU, and FDA standards while leading regulatory interactions with authorities like ANSM and EMA.
You will develop and lead a large multi-layered Quality organization with 8-10 direct reports and over 100 indirect reports, driving a proactive quality culture through continuous improvement initiatives.
Matching Summary
Match Score: 85
Thermo Fisher Scientific is seeking a Quality Director for their Bourgoin, France site, responsible for leading the Quality organization in a pharmaceutical manufacturing environment. The ideal candidate will possess a French Pharmacist degree and significant experience in quality leadership, regulatory compliance, and operational excellence.
Skills & Requirements
Must-have
Qualified Person (QP) registration in France
French Pharmacist degree required
10+ years senior quality leadership experience
EU GMP FDA CFR regulatory compliance expertise
Experience leading regulatory inspections
Fluent French and English language skills
Nice-to-have
CDMO client-facing quality governance experience
Lean Six Sigma operational excellence background
NDA submission support experience
Proven track record in OSD manufacturing
Strong risk-based decision-making culture
Key Requirements
French Pharmacist degree enabling QP registration
10+ years senior Quality leadership experience
Fluent French and English proficiency
Site Quality Lead experience in regulated environment
OSD manufacturing industry experience preferred
Work Rights
Must have French Pharmacist degree for QP registration