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

Clinical Quality Management Associate Director @ Top Biopharma

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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 - Clinical R & D
Industry Pharmaceuticals
Location Asia Japan Tokyo

Job Description Be part of one of the top global biopharmas in the industry. Take lead in the overall improvement of clinical QMS.


Description

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Leads Quality Planning & Implementation: Oversees all quality activities within Japan Development Operations (J-DO), ensuring alignment with global Clinical Quality Management Systems and adapting to regulatory and organisational changes.
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Ensures Inspection Readiness: Guides study teams and collaborates with stakeholders to maintain a constant state of readiness for regulatory inspections (e.g., PMDA, EMA, FDA).
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Drives Continuous Improvement: Collects and analyses quality data, leads issue investigations and CAPA development, and identifies opportunities for quality and process improvement.
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Fosters Global Collaboration & Compliance: Acts as a global quality representative, ensuring consistent process application, managing compliance risks, and integrating regulatory updates into J-DO operations.
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Champions Quality Culture: Serves as a professional role model, promotes ethical behaviour, simplifies procedural documentation, and builds strong relationships with internal and external partners.


Profile

* University degree in scientific or related field
* High fluency in English and Japanese (non-native level speakers will not be selected)
* Extensive experience in the pharmaceutical industry specifically in clinical QA
* Ability to understand quality systems aligned with GCP
* Knowledge in local regulations and compliance


Job Offer

* Competitive salaries and benefits
* Great work life balance
* Hybrid working style and international environment
* Amazing career progression in clinical 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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