Brigitte D'Hautefeuille Email & Phone Number

Paris, Fr

Scope:• Corporate Position - Headquarters • 350 people based in 8 countries / 14 direct reports• 8 Manufacturing plants / 5 CMO / 26 Local affiliates / 250 logistic partners /275 Suppliers Missions: • Provide strategic and tactical leadership to the site quality organizations (Sterile Finished Products Manufacturing sites, API sites & Medical Devices (MD) Sites) and global Quality functions. • Ensure Quality Standards and cGXP requirements are implemented and consistently followedMain achievements: • Readiness inspection of the manufacturing sites - Creation and monitoring of Quality Remediation Plan for sites at compliance risk - Pragmatic management of quality issues with implementation of Return of Experience - Improve in 2023 the production capacity - Zero critical observation or warning letter / 30 inspections/audits received during the 3 years • Proactive participation or lead of Guerbet Projects - Launch of Gadopiclenol in co-marketing - Implementation of Annex 1 of Eu GMP - Eu MDR implementation for injectors • Support the « Make-or-Buy » approach

Villepinte, Île-De-France, France

Scope • Corporate Position - Headquarters • 150 logistic partners based in 70 countries / 3 direct reports - Team of 15 people / 2 distribution centersMissions: • Define the quality strategy for the distribution network in the world • Provide oversight, directives and leadership to define the Quality for Guerbet distribution networkMain achievements:• Certification of 100% of third parties (Audit, Quality Agreements, Quality Council…) in 2 years and implementation of the associated quality strategy and system• Development and creation of the shipping lane qualification process - Secondary transportation risk assessment for 20 countries in 2 years - Retrospective qualification of all shipping lanes (150 lanes) in 2 years• Medical Devices Regulation implementation for imported and/or distributed MD with limited impact on the cost • Switch to “Go direct flow” for China (certification of 2 local affiliates, one warehouse and more of 120 distributors in 12 months) with high positive impact on the market (+33,7%)• Review and harmonization of the quality system in the local Affiliates (Quarterly QP meeting, Self-inspection, Training, Risk Assessment …) with successful HA inspections of the local affiliates

Rueil Malmaison

Scope:• Corporate Position - EMEA/ASIA Pac Headquarters • 80 suppliers based in 70 countries / 3 French distribution centres / 4 direct reportsMissions: • Define the quality strategy for the distribution network in EMEA/ASIA Pac region • Manage the quality department for French distribution centresMain achievements:• Provide quality directives and leadership to define the distribution BMS networkMain achievements:• Certification and maintenance of the suppliers certification (Audit, Quality Agreements, Quality Council…) and review and improvement of the associated quality systems • Critical review of the global logistic investigation system to be focused on major and recurrent deviations and improve efficiency • Review and harmonization of the quality system in the French distribution centres (Quality council, Self-inspection, Training, Validation Master Plan, Risk Assessment …)• Active participation to define the new BMS distribution network and role (redressing, postponement)

Rueil Malmaison

Scope:• Corporate Position - EMEA/ASIA Pac Headquarters • 320 Suppliers used by 5 EMEA/ASIA Pac BMS plants • 30 auditors based in 11 countries Missions: Audit and self inspection activities• Define suppliers quality and audit strategy for EMEA/ASIA Pac region, • Certify and manage the external auditors and self-inspectors teams• Play a positive and proactive role within global networks • Audit of Third Party, Excipient and API suppliers, External Laboratory, DistributorsLocal regulatory activities (18 months)• Creation and deployment of the quality system for the local regulatory entities (20) Support activities (11 months)• Support BMS plant team in crisis situation to provide directives and leadership Pharmacien Responsable Interimaire

Epernon Plant

Scope:• Manufacturing site - Epernon - (Non sterile manufacturing site – 300/350 people)• 45 to 60 people including 15 managers • Validation & Qualification, Quality Control, Quality Assurance, Quality System and Regulatory units Missions: • Manage the quality department of Epernon manufacturing site • Provide oversight, directives and leadership to reach and maintain a high quality standard• Member of CODIR

Hérouville Saint-Clair Plant

Scope: • QA team (5 people) and validation team (3 to 6 people)Mission: • Manage the quality assurance unit of Hérouville St Clair manufacturing site (Sterile and non-sterile manufacturing site for API and finished drugs – 350/450 people)

Hérouville Saint-Clair Plant

Missions:• Check and release the batches • Validate the manufacturing process

Dess - Caae, Institut De L'Administration Des Entreprises

Activities and Societies: Management - Business

Msbm, Biochimie

Pharmacist, Pharmacie Industrielle