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Japan, Vaccine Quality Assurance Manager

Publication date 2025/08/29

Work Location , Expected Annual Income :

Tokyo,12.0M ~ 16.0M

About the Company :

Global European Vaccine Manufacturing Company

Responsibilities :

Main Responsibilities:
Quality Operations related to manufacturing and release of Vaccine :
-Act as CMO Quality site contact and responsible for CMO quality oversight for Vaccine operations.
-Quality representative actively engaged in internal core team meetings and joint meetings with the CMO.
-Responsible for quality oversight of cGMP documents and records (includes but not limited to: batch production records,, Site Lot Protocol, validation protocols/reports, product release documentation, change controls, deviations, CAPA, lab investigations, complaint investigations, product quality review, quality agreements)
-Responsible to review and approve documents in the QA capacity
-Responsible for product release in accordance with approved specifications and procedures Monitor contractor performance to established key performance indicators (KPI) and report and escalate adverse trends.
-Demonstrate understanding of applicable health authority regulations related to manufacture of Vaccines products

Operational Support of CMOs management and Project management
-QA Manager in Japan are responsible for Quality oversight on all pharmaceutical related activities to ensure compliance in respect to the GxP, the marketing authorization, and all applicable procedures.
-Following the main responsibilities as defined above the QA Manager Vaccine provides support and contribute when requested to operational management of CMOs

Support the internal quality activities of the manufacturing and supply teams.
-QA Manager Vaccine participate in maintaining Quality systems, documentation and internal activities such as, but not limited, Budget overview, Site Quality Review, Self Inspection.

Benefits :

Employment Type: Full time employee
Office: Tokyo, Japan
Working Style: Hybrid work model
Budget Range: 12-15mil annual total
Interview Steps: 3
Reporting Line: Head of Quality Manufacturing
Reporting Language: English

Required Experience / Abilities / Skills :

Education and Experience:
-Degree in Pharmacy or Chemistry and at least 5 years of experience in biopharmaceutical manufacturing or QC/QA.
-Experience in CMC Regulatory is highly welcomed.
-Experience in Vaccine is highly welcomed

Soft and technical skills:
-QA experience: 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.
-Experience in communicating with Japanese health authority.
-Attentive to details
-Good communication and negotiation skills to manage stakeholders (authorities, affiliate, CMO, regulatory, etc.)
-Open and eager to learn new challenges.

Languages:
-Native Japanese
-Business level English

Contact Information :

JAC International, Healthcare Team
Kent Gu
Email: k-gu@jac-international.jp

If you are interested, email us for inquiry!

JOB ID : IJB2009694

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