【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）

• 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.

Client Details

• 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.

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

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.

• 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