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Job Description

OBJECTIVES:
The Manager, External Quality Vaccines-Asia will oversee quality assurance activities for late-phase clinical programs and commercial vaccine launches. This role ensures that manufacturing, testing, packaging, and shipment processes comply with Takeda's Quality Management System (QMS), current Valuable Manufacturing Practices (cGMP), and global regulatory requirements. The position requires a strategic focus on quality assurance systems, product technology transfer, and lifecycle management to maintain product quality and compliance across multiple Contract Manufacturing Organizations (CMOs) and global markets.
ACCOUNTABILITIES:
- Provide strategic oversight for quality assurance activities,



ensuring alignment with Takeda’s global quality standards. Responsible for day-to-day interactions with contract facilities (CMOs, CTLs, FTWZs and/or CSPs):

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- Conducts/supports investigations on Good Practice (GMP & GDP) related issues or observations associated with audits, batch records and complaints.
- Reviews and approves (where applicable) manufacturing and testing deviations and investigations into out-of-specification results.
- Supports timely execution and completeness of change management at interface with CMOs (incl. supplier notification of changes) and of internal Takeda change management
- Reviews and approves batch production records and test records.
- Reviews and approves validation documentations
- Reviews and approves shipment or material transfer request
- Performs batch disposition (Diluent, DS, DP, FDP) as per MAH requirements
- Ensures collaboration with and provides guidance to exter

📌 Manager, External Quality Vaccines (India)
🏢 Takeda
📍 India