Japan Quality Director @ Global Biopharmaceutical Leader

求人詳細

Lead quality assurance and compliance for a global biopharmaceutical leader in Japan – a dynamic and impactful role.

■About the company
Our 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 & Responsibilities
As 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

こんな方を求めています

経験・スキル

■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.

学歴

大学卒業以上

募集要項

職種

品質マネージャー, ディレクター, ヘッド

給与

年収 1,800 〜 2,200万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

保険

健康保険　厚生年金保険　雇用保険

受動喫煙防止措置

敷地内禁煙

特長

外資系企業

業種

医療機器・医療品関連

※詳細はお仕事のご紹介時にお伝えします