Lucile Bessueille
F. Hoffmann-La Roche AG
Regional Head Audit & Inspection Europe
SUMMARY Quality leader in Biologics and Cell & Gene Therapy
+20 years’ experience in IMP and commercial Quality
Ability to build, develop and lead global Quality teams
Proven experience with facility start-up, from construction to GMP approval and routine operations
Extensive experience in Health Authority inspections
Quality oversight on CMOs and Manufacturing site of Kymriah (1st CAR-T approved in 2017 by FDA)
PROFESSIONAL EXPERIENCE
July 2017 to present: F-Hoffmann La Roche – Basel (CH)
Head Global Quality Inspection Management
Lead the Global Quality Inspection Management Europe team, supporting Roche sites and CMOs, to ensuring readiness to Health Authority inspections (Pre-approval, routine GMP). Provide guidance for strategy; deliver coaching for inspection readiness and support response process to Health Authorities
Support to Cell & Gene Therapy projects as member of Project Quality teams. Lead the Roche Quality Requirements establishment for Off-the-Shelf ATMPs as part of Roche PQS
2015 to 2017: Novartis Pharma AG – Basel (CH)
Head Product Quality & Contract Manufacturing Operation - Cell and Gene Therapy Quality Unit
Provide the quality end-to-end oversight of cell and gene therapy products at the program level and across the footprint. Ensure robust oversight of external manufacturers, adequate regulatory compliance for clinical supply, launch and commercial phases of the programs in all regions.
Support filing and successful FDA inspections for the approval of Kymriah (1st CAR-T approved in 2017)
2009 to 2015: Novartis Pharma AG – Basel (CH) Global Head Quality, Novartis Biologics
2006 to 2008: Novartis Pharma SAS - Huningue (France) Site Quality Head, Biopharmaceutical Operations
2001 to 2005 Novartis Pharma SAS - Huningue (France) Head of Product Quality Assurance
1998 to 2001: SANGSTAT - Marcy l’Etoile (France) (Now Genzyme/Sanofi) Site Quality Head
+20 years’ experience in IMP and commercial Quality
Ability to build, develop and lead global Quality teams
Proven experience with facility start-up, from construction to GMP approval and routine operations
Extensive experience in Health Authority inspections
Quality oversight on CMOs and Manufacturing site of Kymriah (1st CAR-T approved in 2017 by FDA)
PROFESSIONAL EXPERIENCE
July 2017 to present: F-Hoffmann La Roche – Basel (CH)
Head Global Quality Inspection Management
Lead the Global Quality Inspection Management Europe team, supporting Roche sites and CMOs, to ensuring readiness to Health Authority inspections (Pre-approval, routine GMP). Provide guidance for strategy; deliver coaching for inspection readiness and support response process to Health Authorities
Support to Cell & Gene Therapy projects as member of Project Quality teams. Lead the Roche Quality Requirements establishment for Off-the-Shelf ATMPs as part of Roche PQS
2015 to 2017: Novartis Pharma AG – Basel (CH)
Head Product Quality & Contract Manufacturing Operation - Cell and Gene Therapy Quality Unit
Provide the quality end-to-end oversight of cell and gene therapy products at the program level and across the footprint. Ensure robust oversight of external manufacturers, adequate regulatory compliance for clinical supply, launch and commercial phases of the programs in all regions.
Support filing and successful FDA inspections for the approval of Kymriah (1st CAR-T approved in 2017)
2009 to 2015: Novartis Pharma AG – Basel (CH) Global Head Quality, Novartis Biologics
2006 to 2008: Novartis Pharma SAS - Huningue (France) Site Quality Head, Biopharmaceutical Operations
2001 to 2005 Novartis Pharma SAS - Huningue (France) Head of Product Quality Assurance
1998 to 2001: SANGSTAT - Marcy l’Etoile (France) (Now Genzyme/Sanofi) Site Quality Head