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Updated 2025-03-14
Activated 2025-03-14

【非公開案件 -2000万円〜】品質保証部長(製薬・バイオ医薬品)

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
Industry Pharmaceuticals
Location Asia Japan Tokyo

Job Description *

A global pharmaceutical is seeking an experienced Head of Quality Assurance (Local Quality Officer) to oversee QMS operations, regulatory compliance, and supplier quality management in Japan. This role is critical in shaping the company's quality strategy and compliance framework.


職務内容

* Manage and maintain the Quality Management System (QMS) in compliance with ISO, GMP, GDP, and Japanese regulatory requirements.
* Oversee batch release, change control, complaints, deviations, and recall processes.
* Act as the primary regulatory contact, handling audits, inspections, and compliance matters.
* Ensure supplier quality compliance, including oversight of third-party logistics (3PL) providers.


理想の人材

* 10+ years of experience in pharmaceutical quality assurance, with 7+ years in QMS management.
* Strong knowledge of GMP, GDP, and regulatory requirements in Japan.
* Experience leading QA teams and managing supplier and regulatory relationships.
* Fluent in Japanese and business-level English for global collaboration.
* Strong problem-solving skills, strategic mindset, and ability to influence stakeholders.


条件・待遇

* Hybrid
* ベースボーナス
* 豊富な休暇制度
* 革新的で開放的な企業文化
* 専門スキルを活かせる環境

質と科学への情熱を持つ皆様からのご応募をお待ちしています。今すぐご応募ください。


To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Sobi Tantisakchaichan on +81357337165.
Company Info * A globally recognized leader in pharmaceuticals, playing a key role in healthcare innovation.
* Ideal environment for regulatory and quality professionals to drive compliance excellence.
* Work closely with global quality teams and contribute to international regulatory initiatives.
* Flexible work environment with strong career growth opportunities.
English Level Business Conversation Level (TOEIC 735-860)
Japanese Level Native Level
Salary JPY - Japanese Yen JPY 20000K - JPY 25000K   
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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

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