Position Details

• Department: External Manufacturing and Supply Gen Med Quality Assurance Japan
• Job Title: Quality Manager
• Location: 50% Tokyo, 50% Kawagoe City
• Reports to: Head Quality Operations, External Manufacturing & Supply Japan
• Supervises: None (Direct & Indirect)

Purpose

To ensure quality oversight of a strategic Contract Manufacturing Organization (CMO) and support quality-related activities of External Manufacturing & Supply (EM&S) Japan.

Key Responsibilities

Oversight of CMO Quality Operations(90% weightage)

• Quality agreement:

Ensure and coordinate the update of the QTA with the CMO and related PTS in collaboration with the Sanofi QA managers in charge of the QTA management and change control management.

• Audit/inspection:

Review the Sanofi CMO audit report

Follow-up the CMO audit capa implementation

Support the regulatory inspection of the CMOs

Ensure the capa plan is defined and in place to address the inspection findings.

• KPIs and CMO performance assessment:

Ensure the data collection of the KPIs defined in the Quality agreement

Contribute to the CMO risk ranking in collaboration with the other EM&S JP stakeholders.

Define in collaboration with the EM&S Quality Head and conduct the mitigation plan depending on the risk ranking outcome.

• Quality review

Lead the periodic quality reviews with the CMO

Ensure the follow-up of the actions defined during the quality reviews.

Support the business reviews (quality part)

• Deviation Management

Support the CMOs in the classification of their deviations to be reported to Sanofi.

Perform the coordination of any urgent quality events in collaboration with the EM&S JP stakeholders.

Contribute to the investigation and follow-up of the deviations reported to Sanofi in collaboration with the EM&S QA manager in charge of the deviation management.

Ensure that the CMO CAPAs are defined and implemented and the associated efficiency review in place.

• Change control management

Ensure that the change actions assigned to the CMO are performed in a timely manner.

• Validation, transfer of products

 Ensure that the CAPA actions assigned to the CMO are performed in a timely manner.

Identify the need of validation/revalidation in collaboration with the EM&S Quality managers responsible for change control management, PQR management, transfer/new launch.

• Risk Management

Proactively identify the risks linked to the compliance of the CMO activities

Contribute to the escalation of the quality events linked to the CMO activities.

Contribute to the definition of the mitigation plan of the risk.

• Stability

Ensure that the CMO stability program is available

Collect stability data from the CMO

Contribute to the stability data tracking and trending done by other EM&S stakeholders.

• CMO compliance:

Ensure the CMO compliance to any new regulations or Sanofi directives.

Support Internal Quality Activities of EM&S(10% weightage)

• Budget overview:

Request quotation for the quality activities to the CMO when appropriate.

Ensure the follow-up of the PO.

• Site Quality Review:

Contribute to the EM&S JP quality review

• Self inspection:

Contribute to the self inspection of  EM&S JP quality

Pre-requisites

• Knowledge, Skills & Competencies:
  • Manufacturing process and compliance
  • GQP/GMP Compliance
  • Manufacturing/Laboratory Investigations
  • Change control and Deviation Management
  • Quality Risk Assessment (QRA)
  • Nitrosamine Impurities management
  • ICH Q1-Q3
  • Visual inspection
  • Sterility assurance
• Languages: Fluent in English and Japanese

Qualifications

• Ph.D. in Pharmacy or Chemistry
• 10 years of experience in manufacturing or QC/QA in pharmaceutical