JOB SUMMARY

On the basis of Sanofi quality policy and Japanese regulations, make available to customers high quality products and services through promoting Quality Assurance activities strongly and leading / supporting Japanese Contract Manufacturing Organization in order to ensure quality of pharmaceuticals and cosmetics under the regulatory compliance as a manufacturing and Marketing Authorization Holder (MAH).

Mission of the EMQA:

Ensure that manufacturing and quality control in local Contract Manufacturing Organization comply with Japanese GMP requirements and Sanofi Global Quality Directives from a GQP perspective and contribute to the improvement of product quality and safety.

Objectives:

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

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.

Support Project management team for implementation of new products.

KNOWLEDGE AND SKILL REQUIREMENTS (Minimum requirements for assignment to this job.)

Knowledge And Skills:

  • Fluent English communication skills

  • Daily Japanese communication skills as a minimum

  • Global regulations (EU, US)

  • Global requirements / guideline (PIC/S, ICH, WHO, IPEC, ISO 9001, ISO 13485)

  • Experiences in QA(+QC) area for at least 3-5 years

  • Good communication skill

  • agility with Digital tools

  • Experience of Pharmaceutical environment

Knowledge And Skills Desirable But Not Essential:

  • Pharmacist

  • Regulatory (Packaging insert, Label, Artwork etc.)

  • Japanese regulations (GMP, GQP/GDP, GLP, QMS, Pharmaceutical Low [Pharmaceutical and Medical Device Act])

  • Chemistry (HSE, SDS, DMF, etc.)

  • Cross-functional leadership

  • Self-motivated individual who is comfortable with working independently

  • Makes effective quality decisions with high sense of urgency

  • Experience of Vaccines/Biologics, and aseptic operations is a plus

PRINCIPAL DUTIES AND RESPONSIBILITIES

Briefly describe the major duties and responsibilities for which the job is held accountable

MAJOR DUTIES & RESPONSIBILITIES (what the job does)

END RESULTS EXPECTED (why is it done/impact)

1. Deviation Management (incl. CAPA management)

  • Registration of Deviation in the Database

  • Ensure the investigation is completed by CMO

  • Request analysis of sample and expedition if needed

  • Escalate the investigation to originating site when identified by investigation, and ensure the investigation is completed

  • Provide investigation conclusion to SAKK Qualified Person for Batch decision

  • Participate in evaluation of risk and escalate the risk alert when identified

  • Communicate the decision to CMOs

  • Monitor the deviation activity and generate monthly KPI for reporting to Global

2. Batch Release and Global Release management

Batch release and monitoring (for CMOs without delegation of release)

  • Check that the release documentation provided by CMOs is compliant with GQP regulations

  • Prepare the GQP release form for SAKK Qualified Person

Provide GQP release form to CMOs when decision is made to release the batch on the market

  • Provide signed Pre-shipment Agreement, under Quarantine request, and any documentation necessary to batch reception to CMOs

  • Review the temperature excursion data and escalate Deviation in Global database in case of non conformity

  • Review of Visual Inspection results provided to CMO and escalate Deviation in Global database in case of non conformity

  • Manage the release document provided by manufacturing site and provide them to CMOs for batch release

3. NIID Testing Coordination

  • Coordinate the testing of Sanofi vaccines with the National Institute of Infectious Diseases that are imported to Japan

4. Quality Alert Management

  • Participate in evaluation of risk and escalate the risk alert when identified (pre and post product release)

  • Coordinate the management of quality alert locally and report to Global

5. Audit

  • Participe the in some of the audit of CMOs as a lead auditor or co auditor as per annual audit plan

6. Support

  • Support other Manager within EMQA Japan or divisions (Business Units, Pharmacovigilance, Medical Affairs, External Affairs, Regulatory Affairs, R&D and Supply Chain) with expertized QA approach

7. Promote HSE, People & Culture mentality

  • Develop supportive & comfortable working environment