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Updated 2025-03-29
Activated 2025-03-29
Activated 2025-03-29
【年収最大1,000万円】品質保証マネージャー｜グローバルな医療機器・IVD企業での責任者ポジション（ハイブリッド勤務）
| 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 |
 |
| Industry | Pharmaceuticals |
| Location |
Asia
Japan
Tokyo
|
| Job Description |
* A leading global healthcare company is seeking a QA Manager to oversee quality operations for IVD manufacturing and distribution. This role offers a broad scope across QMS management, regulatory compliance, post-market activities, and leadership of internal audits and quality assurance processes. Description * Lead and maintain QMS operations in line with PMD Act and ISO standards * Manage audits, inspections, and regulatory documentation (labels, SDS, inserts) * Oversee post-market surveillance, complaint handling, vigilance reporting * Execute product release decisions and improve product quality with manufacturers * Support RA tasks including license renewals, applications, and approvals * Serve as the Responsible Person for IVD manufacturing, sales, and hazardous substances * Monitor domestic logistics centers and collaborate with global RAQA teams * Conduct training on regulations and support import documentation * Participate in strategic cross-functional projects and continuous improvement Profile * Licensed Pharmacist with a Bachelor's degree in Pharmacy (required) * Experience in QA for IVD or Medical Device companies * Strong knowledge of QMS, PMD Act, and IVD regulations * Laboratory and regulatory experience preferred * Business-level English communication skills * Detail-oriented, proactive, and strong stakeholder communicator * Comfortable working independently and in a cross-cultural global setting Job Offer * Base Salary: Up to ¥10 million (depending on experience) * Work Style: Hybrid flexibility (Tokyo or Chiba office) * Global Exposure: Direct collaboration with overseas RA/QA and manufacturing teams * Career Growth: Strategic role with potential to expand responsibilities across APAC * Culture: Professional yet collaborative environment, with focus on compliance and innovation To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Sobi Tantisakchaichan on +81357337165. |
| Company Info | * This confidential client is an internationally recognized player in the healthcare industry, known for its commitment to innovation and compliance excellence. With a strong presence in Japan and a global support network, they provide opportunities for growth, cross-functional collaboration, and a clear pathway to leadership within a stable yet forward-thinking environment. |
| English Level | Business Conversation Level (TOEIC 735-860) |
| Japanese Level | Native Level |
| Salary | JPY - Japanese Yen JPY 8000K - JPY 10000K |
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Recruiter
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
