Quality Assurance Manager

Sanofi

Tokyo, Japan
Gxp oversight of contract manufacturing organizations
Manage a portfolio related activities
Drive continuous improvement
EMQA JP is the Quality Unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing, and transport of Sanofi Japan (SAKK) products

Job Summary

  • EMQA JP is the Quality Unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing, and transport of Sanofi Japan (SAKK) products.
  • Your job, as QA Manager will be to drive continuous improvement in CMO manufacturing by managing a portfolio related activities and providing support to CMO management activities like Change Control Requests, leading deviation investigations, and using your findings to deliver positive change.
  • At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Matching Summary

EMQA JP is the Quality Unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing, and transport of Sanofi Japan (SAKK) products.

Skills & Requirements

Must-have

  • GxP oversight of Contract Manufacturing Organizations
  • manage a portfolio related activities
  • drive continuous improvement
  • Quality Operations related to manufacturing and release
  • review and approve documents in QA capacity
  • product release in accordance with approved specifications

Nice-to-have

  • Attentive to details
  • Good communication and negotiation skills
  • Open and eager to learn new challenges
  • Experience in communicating with Japanese health authority

Key Requirements

  • Degree in Pharmacy or Chemistry
  • at least 5 years of experience in biopharmaceutical manufacturing or QC/QA
  • Experience in CMC Regulatory is highly welcomed
  • Experience in sterile is highly welcomed
  • understanding of GMP/GQP/GDP
  • experience in validation (process, analytical, shipping)
  • batch record review
  • product release
  • Knowledge of biological manufacturing (cell culture, sterile)
  • Familiarity or experience in reviewing Japanese dossier
  • Native Japanese
  • Business level English

Work Rights

Not specified

Tailored Resume

Cover Letter