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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 Good 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.
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, and/or CSPs):
Ensures collaboration with and provides guidance to external manufacturing, project management, supply chain, Manufacturing Science and Technology and CMOs to ensure Q-Systems compliance and manages compliant and timely closure of deviations, CAPA, change controls and interim batch assessment as applicable.
Executes regular Person in Plant QA oversight and leverages insights to ensure compliance and drive performance and continuous improvement.
Manages document life cycle (incl. reviews, approval, make-effective and retirement) of GMP related documents, such as master batch records, risk assessments, etc. according to Takeda QMS requirement.
In early stages of project, support, review and approve development, technology reports where applicable. Review of submission document ensuring data integrity to source data.
Provides guidance for technology transfer and validation of manufacturing processes, ensures compliance to Q-systems and regulatory guidances; reviews and approves applicable documents.
Supports regulatory or Takeda global audits (including product specific inspections at CMOs), VBU Self-Assessment activities and risk mitigation activities identified in Risk Register.
Maintains culture of teamwork, cooperation and continuous improvement.
Originally posted on Himalayas