QMRA Sr. Manager Japan

求人詳細

Lead and grow a dynamic team, driving quality and regulatory excellence within a cutting-edge biotech company in Japan.

■About our client
Join a global biotech leader renowned for its innovation and commitment to patient care. Help improve healthcare outcomes in Japan using cutting-edge technologies and therapies.

■Position Overview
You will be responsible for leading and developing a team dedicated to Quality Management, Regulatory Affairs, and Compliance. You will build and maintain strong relationships with various stakeholders, ensuring the highest standards of quality and regulatory compliance are met across all operations. You will play a crucial role in shaping the company's quality strategy and ensuring its successful implementation across the organization.

■Main tasks
・Lead the development and implementation of robust quality management systems.
・Oversee regulatory affairs activities, ensuring compliance with all relevant regulations.
・Manage and mentor a team of quality and regulatory professionals.
・Develop and deliver training programs on quality and regulatory compliance.
・Conduct regular audits and inspections to ensure compliance.
・Collaborate with cross-functional teams to identify and mitigate risks.

If you are interested in this position, we look forward to your application.

#LI-Hybrid
#LI-KN

こんな方を求めています

経験・スキル

■Requirements
・Minimum of 10 years of experience in Quality Management and/or Regulatory Affairs within the pharmaceutical or biotechnology industry.
・Proven track record of success in leading and developing high-performing teams.
・Expert knowledge of Japanese and international regulatory requirements (PMDA, EMA, FDA).
・Strong understanding of quality management systems (e.g., ISO 13485, GMP).
・Excellent communication, interpersonal, and presentation skills.
・Business level proficiency or higher in Japanese and English.
・Experience working in a global organization is highly preferred.
・Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.
・Strong leadership and problem-solving skills.
・Experience with change management and process improvement initiatives.

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 800 〜 1,350万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

試用期間

有り

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

業種

医療機器・医療品関連

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