Job Description

社名
社名非公開

職種
品質マネージャー, ディレクター, ヘッド

業務内容
■Work conditions・Temp-to-Perm・Telework possible・Location: Tokyo・Hourly wage: Up to ¥3,000 - 5000 (Annual salary: Up to ¥8 million) ーーーーーーーーーーーーーLead a dynamic team, ensuring top-tier quality in a cutting-edge life sciences environment. ■About the companyOur client is a pioneering life sciences company committed to delivering innovative pharmaceutical solutions. They foster a collaborative and supportive work environment where continuous learning and professional growth are highly valued. They are seeking a highly skilled and experienced QA Manager to join their team.■Role & ResponsibilitiesYou will oversee all aspects of quality assurance, ensuring compliance with Japanese regulatory requirements. You will lead a team, mentor junior staff, and collaborate with cross-functional teams to guarantee the highest quality standards in all processes, from research and development to commercialization. You will play a pivotal role in the company's success.■Main tasks include・Lead preparation of pharmaceutical documents for submission to Japanese regulatory authorities.・Ensure compliance with regulations related to ethical pharmaceuticals, OTC, and regenerative medical products.・Conduct GMP audits of manufacturing sites.・Review QA submission documents, assess change controls, and manage batch release of commercial products.・Oversee QMS, SOPs, vendor audits, and market complaint handling.・Support GMP inspections by PMDA and other relevant authorities.・Manage departmental goals, budgets, and training of subordinates.If you are interested in this exciting opportunity, apply now.We look forward to hearing from you.#LI-Hybrid

求められる経験
■Requirements
・Minimum 10 years of experience in a QA role within the pharmaceutical industry.
・Minimum 3 years of experience as a QA Manager or QC Manager for Type I, Type II, or regenerative medical products.
・University degree or higher in a biological science (medicine, pharmacy, science, agriculture, etc.); doctoral degree preferred.
・Expert knowledge of Japanese pharmaceutical regulations (PMDA and MHLW).
・Proven experience conducting GMP audits and supporting regulatory inspections.
・Experience reviewing manufacturing documents, deviations, change controls, and CAPAs.
・Excellent written and verbal communication skills in English and Japanese.
・Proven ability to lead and manage a team.
・Experience preparing presentations and communicating complex information clearly.
・Strong understanding of QMS, SOP development, and vendor management.

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収600 ～ 800万円

賞与
-
雇用期間
期間の定めなし

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