Manager – Quality Assurance & Distribution (Japan)

求人詳細

Be a pioneer in global quality assurance. Join us in delivering real impact.

【About the Company】
Our client is a global pharmaceutical leader focused on improving health through innovative medicines. The Japan team unites experts to uphold quality standards, emphasizing trust, safety, and an inclusive, growth-oriented culture.

【Position Overview】
As the Quality Assurance Manager, you will lead GQP activities for product distribution and launches, ensuring compliance with Good Distribution Practices (GDP) and product release standards. You will collaborate closely with Global IOPS teams to maintain high quality in the Japanese market.

【Responsibilities】
・Oversee quality management tasks: GQP release, inspection, change control, and deviation handling
・Create and maintain quality agreements with suppliers
・Address and resolve quality-related complaints, and execute improvement programs
・Manage document control, including Global SOPs and related documents
・Coordinate with PMDA and Tokyo Metropolitan Office (including inspections)
Investigate quality defects and conduct follow-up on CAPAs
・Conduct training for QA team members and perform GQP self-inspections
・Implement and maintain quality systems (document management systems)

Apply now to be part of a team setting global standards for quality.
#LI-Hybrid

こんな方を求めています

経験・スキル

・Bachelor’s degree in a scientific discipline; advanced degree preferred
・Pharmacist license preferred
・7+ years of GMP/GQP experience in the pharmaceutical industry
・Expertise in quality assurance, quality control, manufacturing control, and CMC regulatory compliance
・Experience in handling quality-related complaints
・Ability to support GDP operations for wholesalers and transporters
・Business-level English proficiency (reading and writing required; speaking/listening skills a plus)
・Strong communication skills to foster positive relationships across departments

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 1,000 〜 1,400万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

試用期間

無し

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

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