japan quality director @ global biopharmaceutical leader.

Lead quality assurance and compliance for a global biopharmaceutical leader in Japan – a dynamic and impactful role.■About the companyOur client is a leading global biopharmaceutical company dedicated to developing and delivering life-saving therapies. They are committed to high ethical standards and a collaborative work environment. The Japan subsidiary plays a critical role in their global operations.■Role & ResponsibilitiesAs the Japan Quality Director, you will be the champion of quality assurance and compliance within the Japan market. You'll ensure adherence to all local regulations and global company standards, while acting as a key liaison between the Japanese subsidiary and global quality teams. You will build and maintain strong relationships with internal and external stakeholders, driving continuous improvement in quality systems and processes. This is a highly visible role offering significant influence and impact.■Main tasks include- Implement and maintain the Local Quality Management System (QMS).- Oversee quality control for pharmaceutical products, ensuring compliance with GMP/GDP standards.- Manage deviations, CAPAs, complaints, and change control processes.- Lead supplier management, including qualification and selection of new vendors.- Represent the company with health authorities and other external stakeholders.- Collaborate with global quality teams, ensuring consistent application of quality standards.- Manage and develop a team of quality assurance professionals.- Lead internal audits and inspections, ensuring regulatory compliance.- Manage product recalls and field actions, collaborating with various teams and stakeholders.If you are interested in this exciting opportunity, please apply now!We look forward to hearing from you.#LI-Hybrid#LI-KN

求められる経験
■Requirements
- Bachelor's degree in pharmacy, life sciences, or a related field.
- Minimum 10 years of experience in the pharmaceutical industry, with at least 7 years in Quality Management Systems.
- Expert knowledge of GMP, GDP, and Japanese pharmaceutical regulations.
- Proven experience leading and managing a team of quality assurance professionals.
- Strong understanding of quality risk management principles and techniques.
- Excellent communication and collaboration skills, including fluency in Japanese and English.
- Proven ability to interact effectively with health authorities and external partners.
- Strong leadership skills with the ability to build consensus and drive results.
- Experience with SAP systems is preferred.
- Experience in product recall and field action 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1,800 ～ 2,200万円

賞与
-
雇用期間
期間の定めなし