Brigitte D'Hautefeuille

Brigitte D'Hautefeuille Email and Phone Number

Interim Quality Manager @ Merck Healthcare
Paris, FR
Brigitte D'Hautefeuille's Location
Greater Paris Metropolitan Region, France
About Brigitte D'Hautefeuille

Pharmacist by education and rich of a strong Quality Pharmaceutical responsibilities, I’m recognized as an experienced and respected leader in Quality management (Site and headquarter). Passionate by the pharmaceutical industry and, accountable and pragmatic person, focused of objectives and efficiency, I’m constantly leveraged to develop and motivate high performing teams delivering excellent results, including in adverse conditions or crisis situation.Key competencies:• All aspects of Quality technical operations including Manufacturing, Packaging, Maintenance, Control, Transport and Distribution of Pharmaceutical Products. • All Quality Systems: Qualification/Validation, Quality Control, Investigation, Deviation, CAPA management, Audit/Inspection, Change control, Compliance and Risk Assessment.• Matrix environment and Multi–cultural (EMEA/ASIA Pac/US) • Coaching and development of team• Demanding and caring leader.Others skills: GMP/GDP and ISO 13485, Leadership, Project management, Continuous improvment, Problem solving, Quality culture, Feel free to contact me through LinkedIn.

Brigitte D'Hautefeuille's Current Company Details
Merck Healthcare

Merck Healthcare

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Interim Quality Manager
Paris, FR
Website:
guerbet.com
Employees:
1957
Brigitte D'Hautefeuille Work Experience Details
  • Merck Healthcare
    Interim Quality Manager
    Merck Healthcare
    Paris, Fr
  • Guerbet
    Quality Director Technical Operations
    Guerbet Sep 2021 - Present
    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
  • Guerbet
    Global Quality Distribution Head
    Guerbet Jul 2017 - Sep 2021
    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
  • Bristol-Myers Squibb
    Quality And Compliance Distribution Associate Director
    Bristol-Myers Squibb Jan 2016 - Jun 2017
    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)
  • Bristol-Myers Squibb
    External Audit And Compliance Associate Director
    Bristol-Myers Squibb Apr 2010 - Dec 2015
    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
  • Bristol-Myers Squibb
    Quality Head And Qualified Person
    Bristol-Myers Squibb Mar 2005 - Apr 2010
    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
  • Schering-Plough Research Institute
    Qa Manager
    Schering-Plough Research Institute Jun 1996 - Sep 2004
    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)
  • Schering-Plough Research Institute
    Quality Control And Quality Assurance Assistante
    Schering-Plough Research Institute Jun 1995 - Jun 1996
    Hérouville Saint-Clair Plant
    Missions:• Check and release the batches • Validate the manufacturing process

Brigitte D'Hautefeuille Education Details

Frequently Asked Questions about Brigitte D'Hautefeuille

What company does Brigitte D'Hautefeuille work for?

Brigitte D'Hautefeuille works for Merck Healthcare

What is Brigitte D'Hautefeuille's role at the current company?

Brigitte D'Hautefeuille's current role is Interim Quality Manager.

What schools did Brigitte D'Hautefeuille attend?

Brigitte D'Hautefeuille attended Université De Caen Normandie, Université De Caen Normandie, Faculté De Pharmacie De Caen.

Who are Brigitte D'Hautefeuille's colleagues?

Brigitte D'Hautefeuille's colleagues are John Fröhlich, Malika Kerkoub, Ivanna Pineda, Carey Leung, Cpa, Santo Celine, Larry Gardner, Michael Callahan.

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