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Correlation Ventures

EM QA Manager New Product Launch



Product, Quality Assurance
Tokyo, Japan
Posted on Wednesday, October 25, 2023

available to customers high quality products and services through promoting Quality Assurance activities strongly and leading / supporting Japanese CMOs in order to ensure quality of pharmaceuticals and cosmetics under the regulatory compliance as a manufacturing and marketing authorization holder.

Mission of the EMQA:

Ensure that manufacturing and quality control in local toll manufacturers complies with Japanese GMP requirements and IQC Directives from a GQP perspective and contribute to the improvement of product quality and safety.


Good Quality Practices (GQP) activities - GQP is a unique system defined in Japanese PAL.

GQP activities are necessary to ensure the appropriate management of quality for products & systems as MAH.

It includes document management (SOPs, records…), supplier/manufacturer management, batch release for the market, risk management for quality events, and any other relevant activities.


  • Education/training regarding GQP, GMP and GDP.
  • Knowledge of Japanese pharmaceutical laws, regulations and requirements related to CMC and QA.
  • Experience of Vaccines/Biologics, and sterilization
  • Audit execution skill
  • Negotiation and good communication skill
  • Fluent in English and Japanese
  • Able to go to working locations in Japan : Tokyo Hatsudai (Sanofi office) and regular visits of CMOs in Japan

Knowledge And Skills Desirable But Not Essential:

  • Regulatory (Direction insert, Label, Package of Artwork e.t.c)
  • Chemistry (HSE, SDS e.t.c)



  • Prepare and participate in the project meeting for the new product launch to identify and plan the Quality actions needed for timely launch.
  • Collaborate with EM Project team for the new product launch plan execution and continuously update the progress on Quality topics
  • Prepare the plan for Quality task through collaboration with Sending site Quality, CMO Quality, GQP and Affiliate regulatory.
  • Prepare and align CMO for the NDA submission plan and task needed for execution at CMO through collaboration with Affiliate regulatory and GQP.

Due diligence:

  • Participate and plan Quality due diligence through planning Quality audits of identified CMO.
  • Ensure the CMO approval and Quality Due diligence performed.
  • Participate and support CMO in PAI inspection planned at CMO through coordination with Affiliate regulatory.

Method transfer and validations:

  • Apply MRA /MOU for the new product launch
  • Plan and coordinate the Analytical method transfer from sending site to CMO Quality.
  • Coordinate and align and approve transfer protocol from Sender site to CMO as per Sanofi guidelines.
  • Align the Specifications in AMT as per the NDA dossier plan for submission through collaboration with Regulatory.
  • Perform and approve the product validation plan with CMO.
  • Perform the shipping validation with the Sender site and align the Japan market regulation in validation protocol.
  • Coordinate and participate the shipping validation of drug product from CMO to distribution center through collaboration with supply chain team member.
  • Coordinate and arrange the samples required for method transfer from sender site to CMO’s


  • Ensure Quality agreement and product technical specifications are approved before launch timely manner.
  • Align Quality agreement and Product technical specification with API supplier as per Sanofi Guideline
  • Align Quality agreement and Product technical specification with Bulk product supplier as per Sanofi Guideline
  • Align Quality agreement and Product technical specification with CMO as per Sanofi Guideline.
  • Collaborate with GQP members for Quality agreement and product technical specification (as per Dossier).
  • Prepare and align The Visual inspection specifications and standards with Bulk manufacturing site and GQP.
  • Align COA and COC format for bulk supplies for the product as per the registered dossier.
  • For Vaccine and Biological product ensure the valid and approved NIID protocol from Affiliate regulatory , GQP and NIID testing lab authority is available at CMO timely manner

Validation Support at CMO site:

  • in case of Vaccine and biologic products ensure the CMO oversite by CMO site visit.
  • Participate at CMO site for the oversite of validation batches and ensure smooth transfer during the Method transfer as well as validation activity.
  • Management of deviations on bulk samples and during the transfer and validation activity through collaboration with sender site, GQP and CMO quality.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.