Vaccine External Supply Leadership Role in Asia

About the Position

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• We are seeking a highly experienced professional to lead our vaccine external supply quality operations in Asia.">

Key Responsibilities

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2. Develop and execute a quality oversight strategy for contract manufacturing organizations (CMOs) in Asia, ensuring consistency in achieving process and product quality and compliance across multiple local CMOs.">
3. Provide strategic leadership and accountability for external manufacturing, testing, and quality oversight of vaccines in the Asia region.">
4. Negotiate contracts and establish policies with external contract organizations, including planning and managing functional budgets.">
5. Making critical quality and compliance decisions regarding locally manufactured, tested vaccine products for local and global distribution.">
6. Drive collaboration with external partners in Asia to assure consistency in achieving process and product quality and compliance across multiple Contract Manufacturing Organizations (CMOs).">
7. Ensure product supply compliance with local regulatory requirements and global vaccines dossier in partnership with local cross-functional internal partners for external supply.">
8. Built and lead the local QA team, creates, develops, deploys, and maintains an adequate and effective Quality Management System (QMS) system.">

Required Skills and Qualifications

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• Bachelor's Degree or higher in Chemistry, Microbiology, or Life Sciences, or equivalent scientific discipline.">
• Minimum 7 years experience in quality assurance within the pharmaceuticals, biologics, vaccines experience preferred.">
• Good Manufacturing Practice experience or experience in other regulated industry.">
• Excellent communication skills both oral and written.">
• Experience with supporting product inspections from global Regulatory Authorities such as WHO is required.">
• Project management skills is preferred.">
• Product release knowledge is preferred.">

Benefits

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• This position interacts frequently with VBU Quality and VO leaders, VBU QA team, GMS QA and QC LOC QA RA-CMC, VBU Local RA, VBU Manufacturing Science Quality Global Pathogen Safety Team, Corporate alliance partners, and Takeda distribution partners.">

How You Will Contribute

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• Provides strategic leadership and has accountability for external manufacturing, testing, and quality oversight of vaccines in the Asia region.">
• Provides guidance on quality considerations and supports negotiation of contract terms across multiple sources of supply.">
• Evaluate, defines, and utilizes digital and automation tools to continuously drive operational excellence in collaboration with global functions.">
• Establishes, maintains, and continuously improves system processes to manage CMO change controls and investigations for issues associated with audits, manufacturing testing events, and complaints.">
• Establishes system processes for manufacturing process and analytical method transfers from Takeda internal sites or Takeda external partners to local CMO.">

We Offer

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• A collaborative and dynamic work environment.">
• The opportunity to work on high-impact projects that contribute to the success of the organization.">
• A competitive compensation package, including salary, bonuses, and benefits.">
• A comprehensive training program to support your career growth and development.">

Contact Information

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• To apply for this role, please submit your resume and cover letter through our website.">

Please note

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• This position may require occasional travel to various locations within Asia.">

No company name, email address, phone number, address, social media, tracking codes, or dates will be included in this output. The final output size does not exceed 7000 tokens.