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Updated 2025-05-02
Activated 2025-05-02

External Quality Associate Director @ Global Leading Biopharma

This posting is managed by: Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
Company Name Company is not publicly visible
Job Type
Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
Medical/Pharmaceutical/Bio/Fabric/Food - QA/QC
Medical/Pharmaceutical/Bio/Fabric/Food - Manufacturing Technology/Manufacturing Management
Industry Pharmaceuticals
Location Asia Japan Tokyo

Job Description Be part of one of the top global biopharmas in the industry. Take lead in quality management for external suppliers/manufacturers.


Description

*

Oversee and manage the quality activities of assigned external suppliers within procurement Quality global teams, including change control, product quality complaints, and issue management.
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Ensure the establishment and maintenance of quality Agreements between the business and external suppliers, as well as company Operations Sites.
*

Support Quality Professionals in managing supplier and product supply chain quality within assigned categories.
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Prepare and submit supplier quality assessments, and handle regulatory agency interactions, including inspections at external suppliers and company sites.
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Lead quality initiatives for NPI, new supplier introductions, strategic sourcing, process optimization, and product transfer projects related to supplier quality management.


Profile

* University degree in scientific or related field
* Experience in QA in the global pharmaceutical industry
* Strong understanding of cGMPs, QMS, and other GxPs
* High fluency in English and Japanese (non-native level speakers will not be selected)
* Ability to work cross functionally as well as communicate with global stakeholders
* Rich understanding of local regulations/compliance


Job Offer

* Competitive salaries and benefits
* Great work life balance
* Hybrid working style and international environment
* Amazing career progression in QA
* Work with industry leaders who are solving various unmet medical needs




Page Group Japan is acting as an Employment Agency in relation to this vacancy.
Company Info * One of the top global biopharmaceutical companies in the industry
* Rich development pipeline specializing in oncology, rare disease, cardiovascular, infectious diseases, etc.
* Patient-centric and scientific focused organisation for various unmet medical needs
* Hybrid working style
* International environment with extensive global collaboration
English Level Business Conversation Level (TOEIC 735-860)
Japanese Level Native Level
Salary JPY - Japanese Yen JPY 12000K - JPY 15000K   
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