Job opening - QMRA Sr. Manager Japan in 東京23区 | Randstad

summary

東京23区, 東京都
¥8,000,000 - ¥13,500,000 per year, 年収800 ～ 1,350万円
permanent

job category
other

job details

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 ...

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

求められる経験
■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.

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800 ～ 1,350万円

賞与
-
雇用期間
期間の定めなし

show more

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

求められる経験
■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.

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800 ～ 1,350万円

賞与
-
雇用期間
期間の定めなし

show more

experience
■Requirements ・Minimum of 10 years of experience in Quality Management and/or Regulatory Affairs wit

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