Job opening - Head of Commercial Operation QA @ Global Pharma in 東京23区 | Randstad

summary

東京23区, 東京都
¥15,000,000 - ¥20,000,000 per year, 年収1,500 ～ 2,000万円
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 ...

■About our Client: Our client is a global leader in pharmaceuticals, known for their dedication to advancing healthcare through innovative solutions and high-quality products. Committed to ensuring a stable and secure supply of medicines, with a focus on compliance, quality, and trust. This role is based in their Japan subsidiary, which values integrity, collaboration, and excellence. The company fosters a dynamic and inclusive work environment where professional growth and development are highly encouraged.■Summary of the Position:As the Head of Commercial Operations QA, you will play a pivotal role in ensuring the highest standards of quality and compliance across all products and operations in Japan. ■Responsibilities:・Oversee quality assurance processes, ensuring full adherence to local and global regulations, and lead a team responsible for quality control and reliability assurance. ・Working closely with internal departments and external partners, you will manage critical functions such as product release, change control, deviations, and recall procedures. ・Be instrumental in maintaining a positive relationship with regulatory bodies and key stakeholders, driving continuous improvement and operational excellence. ・In addition, you will focus on developing talent within your team, ensuring a strong pipeline of future leaders.

求められる経験
■Skills & Experience Required:
・10+ years of experience in quality assurance within the pharmaceutical or biotech industry.
・Strong understanding of local and global regulatory requirements for GXP compliance.
・Hands-on experience with quality systems and compliance activities (GQP, GMP, GDP).
・Familiarity with CMC processes, including validation and quality control testing.
・Experience interacting with regulatory bodies (e.g., EMA, FDA, PMDA) and managing compliance.
・Proven leadership skills with the ability to develop and mentor teams.
・Strong interpersonal skills for managing relationships with external partners and stakeholders.

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1,500 ～ 2,000万円

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
■About our Client: Our client is a global leader in pharmaceuticals, known for their dedication to advancing healthcare through innovative solutions and high-quality products. Committed to ensuring a stable and secure supply of medicines, with a focus on compliance, quality, and trust. This role is based in their Japan subsidiary, which values integrity, collaboration, and excellence. The company fosters a dynamic and inclusive work environment where professional growth and development are highly encouraged.■Summary of the Position:As the Head of Commercial Operations QA, you will play a pivotal role in ensuring the highest standards of quality and compliance across all products and operations in Japan. ■Responsibilities:・Oversee quality assurance processes, ensuring full adherence to local and global regulations, and lead a team responsible for quality control and reliability assurance. ・Working closely with internal departments and external partners, you will manage critical functions such as product release, change control, deviations, and recall procedures. ・Be instrumental in maintaining a positive relationship with regulatory bodies and key stakeholders, driving continuous improvement and operational excellence. ・In addition, you will focus on developing talent within your team, ensuring a strong pipeline of future leaders. ...

求められる経験
■Skills & Experience Required:
・10+ years of experience in quality assurance within the pharmaceutical or biotech industry.
・Strong understanding of local and global regulatory requirements for GXP compliance.
・Hands-on experience with quality systems and compliance activities (GQP, GMP, GDP).
・Familiarity with CMC processes, including validation and quality control testing.
・Experience interacting with regulatory bodies (e.g., EMA, FDA, PMDA) and managing compliance.
・Proven leadership skills with the ability to develop and mentor teams.
・Strong interpersonal skills for managing relationships with external partners and stakeholders.

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1,500 ～ 2,000万円

賞与
-
雇用期間
期間の定めなし

show more

experience
■Skills & Experience Required: ・10+ years of experience in quality assurance within the pharmaceutic

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