Christophe Haentzler

About

- Docteur en Pharmacie, Pharmacien Responsable délégué - Solide expérience en Assurance Qualité: Expérience combinée de 20 ans dans l'industrie pharmaceutique (fabrication de stylos injectables d'insuline, Lilly France, fabrication de formes sèches, liquides et pâteuses, Pierre Fabre) et deux ans et demi dans les dispositifs médicaux (aiguilles, Becton Dickinson) - Expérience reconnue dans le management (team building, gestion des conflits, développement des collaborateurs) - Expériences multiples dans l’amélioration continue : Six sigma green belt, Lean manufacturing, Root cause analysis. - Gestion des audits cGMP, Device Quality system, ISO 13485 et BPF Spécialités : Pharmaceutical manufacturing regulations (US GMP, Europe GMP), Medical device regulations (ISO13485), Six Sigma green belt, Lean manufacturing, Root cause analysis, Japan quality, Computer system validation, Quality Audit support, Risk management, Team management.

Experience

• GSK (7 yrs 11 mos)
  • Global Steriliy Assurance, Quality Engineering, Devices Senior Director
    Oct 2024 - Present · 1 yr 10 mos

    Management of GSK global quality team in charge of Sterility Assurance, Quality engineering, Cleaning Validation, E&L and Medical devices

  • Global Director Sterility Assurance Expertise and Knowledge Management
    Sep 2018 - Present · 7 yrs 11 mos

• QA Director at Novartis
  Jan 2016 - Aug 2018 · 2 yrs 8 mos

  QA Director for the NVS / Alcon Puurs manufacturing site including all main QA/ QC departments : QA Systems, QA Operations, Chemistry and Microbiological Laboratories, Supplier Quality Assurance and Regulatory Compliance. Sterile Manufacturing site of 1350 FTE

• QA Director at Alcon Laboratories, Inc.
  Sep 2013 - Jan 2016 · 2 yrs 5 mos

  QA Systems, QA Operations, Chemistry and Microbiological Laboratories, Supplier Quality Assurance and Regulatory Compliance. Manufacturing site of 350 FTE Barcelona Plant, Spain and Portugal affiliates

• Responsable Qualité Site at Pierre Fabre
  Jun 2011 - Sep 2013 · 2 yrs 4 mos

  Responsable Assurance Qualité du site de fabrication de Gien. Management de toute l'équipe Assurance Qualité du site (30 personnes) : qualification, validation des procédés, validation de nettoyage, assurance qualité opérationnelle (gestion des non conformités et des réclamations), formation qualité, système qualité et support réglementaire. Gestion des audits externes et internes

• Quality Engineering Manager at Becton Dickinson
  Dec 2008 - Jun 2011 · 2 yrs 7 mos

  Manage the work activities of quality engineering department (team of 3 quality engineers, 11 quality operators and indirectly 16 quality operators on shift in charge of QC inspection, batch release, non conforming product investigation, change control management). Ensure compliance with ISO 13485 and lead SPC software implementation and lean sampling methodology events