Job Description

社名
社名非公開

職種
薬事、メディカルライティング

業務内容
Lead QA initiatives in Japan, ensuring compliance and driving continuous improvement within a dynamic, global healthcare company.■About the companyOur client is a leading global medical technology and digital solutions innovator, committed to creating a world where healthcare has no limits. They foster a culture of collaboration and continuous learning, valuing diverse perspectives and contributions to building a healthier world.■Role & ResponsibilitiesYou will lead the Quality Assurance function in Japan, ensuring compliance with regulations (GQP ministry ordinance) and contributing to the company's ongoing growth. You'll own key QA processes, manage quality evaluations across various sites, and support continuous improvement initiatives. You will also act as a key point of contact with regulatory bodies, ensuring compliance and proactive risk management.■Main tasks include・Lead the preparation and execution of Quality Management Reviews.・Manage quality evaluations of warehouse operations, manufacturing sites, and external laboratories.・Develop and maintain QA systems, rules, and processes to ensure compliance.・Support continuous improvement activities and local business growth.・Engage in regulatory impact assessments and devise implementation strategies.・Manage compliance assessment and remediation plans.・Support global supplier quality audit activities.・Work with local and global teams to maintain product quality excellence.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
・Bachelor's degree in a relevant scientific or technical field.
・7+ years of experience in the pharmaceutical or healthcare industry in a QA role.
・3+ years of supervisory or managerial experience in a pharmaceutical QA environment.
・Proficiency in MS Office suite and experience with eQMS and eDMS systems.
・Experience with regulatory requirements (GMP, GDP, GQP).
・Excellent problem-solving and analytical skills.
・Strong communication skills in both Japanese and English.
・Proven ability to lead and manage teams effectively.
・Experience with CAPA processes and change control management.
・Experience working with regulatory agencies (e.g., PMDA).

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1,000 ～ 1,300万円

賞与
YES／有り
雇用期間
期間の定めなし

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