Vaccine External Supply Quality Manager, Asia Lead
1 day ago
As a Vaccine External Supply Quality Manager, Asia Lead at Takeda, you will be responsible for creating and leading an effective quality oversight organization. You will design, establish, and continuously improve a Quality Management System to ensure consistency in achieving process and product quality and compliance across multiple local Contract Organizations (CMOs, Contract Testing Organization, Distribution Organization) for clinical trial and commercial material.
You will be accountable for critical quality and compliance decisions regarding locally manufactured, tested vaccine products for local and global distribution. In close collaboration with internal teams such as Vaccine Operations, Regulatory Affairs, and Legal team, you will negotiate contracts, and establish policies with external contract organizations. Planning and managing functional budget including budget for work packages/activities at contract organization is also a key responsibility.
Main Responsibilities
- Provide strategic leadership and have accountability for external manufacturing & testing quality oversight of vaccines in the Asia region. Provide guidance on quality considerations and supports negotiation of contract terms across multiple sources of supply. Establishes & maintains contracts/policies/procedures. Responsible for making critical quality and compliance decisions regarding vaccine process & products manufactured/tested at Asia CMOs, including clinical trial material, commercial material, and starting (cell banks and virus banks) material.
- Drive collaboration with external partners in Asia to assure consistency in achieving process / product quality and compliance across multiple Contract Manufacturing Organizations (CMOs).
- Ensure product supply, compliance with local regulatory requirements, and global vaccines dossier in partnership with local cross functional internal partners for external supply, Regulatory Affairs, project management, process development and VBU Quality and Global Quality and regulators.
- Buils and leads the local QA team. Creates, develops, deploys and maintains an adequate and effective QMS system. Ensures timely execution of Quality Assurance and Quality Operations tasks and appropriate cGMP oversight to ensure successful tech transfer and subsequent commercial supply continuation. Shapes the long-term strategy and framework for vaccines External Supplier Quality in the region; including day to day operations such as review & approval of batch records, investigations, documents, change control, submission of batch specific documents to local authorities, batch disposition, process and analytical method performance monitoring and trending.
- Establishes, maintains, and monitors supplier files including Quality Agreements with CMOs and their suppliers.
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