メディカル・バイオ - メディカルGQP・GMP・品質保証・品質管理
メディカル・バイオ - 品質保証

This role is responsible for quality assurance of the company’s products in Japan, including market release, import monitoring, maintenance of local QMS/GQP, regulatory authority interactions, audits, and self-inspections. The position collaborates cross-functionally to ensure compliance, manage quality metrics, resolve issues, and fulfill MAH responsibilities, while leading inspection readiness and engagements with Japanese health authorities.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

・Bachelor’s degree in medicine, dentistry, pharmacy, veterinary medicine, or biology or related field
・Minimum of 5 years progressive experience in medical, pharmaceutical or biologics quality systems’ roles
・Experience with product import lot disposition, deviation and change control management preferred
・Proficiency for reading and writing in English
・Strong working knowledge of and ability to apply cGMP principles in conformance to Japanese and US
・Broad experience across areas like Quality Assurance and/or Quality Systems and understanding of parenteral and aseptic operations is beneficial
・Previous experience presenting and responding to regulatory agency inspections
・Comfortable interacting with regulatory agencies as needed

■職種未経験者：不可