Quality Assurance and Distribution Oversight Manager @ Global growing biopharma

求人詳細

A leading biopharmaceutical company is seeking a Quality & Distribution Oversight Manager to support its mission of transforming science into life-changing medicines for patients with serious diseases.

This role is responsible for ensuring product quality and distribution within the Japanese market by implementing and managing the quality management system in collaboration with global teams. It is an opportunity for an individual to make a meaningful impact on patients in a dynamic and innovative environment.
The ideal candidate is proactive , detail-oriented , and possesses strong collaborative and communication skills to work effectively with global stakeholders.

■Key Responsibilities:
- Lead and coordinate Good Quality Practice (GQP) operations related to pharmaceutical distribution and product launches.
- Monitor and ensure proper product distribution in compliance with Good Distribution Practice (GDP) regulations.
- Collaborate with the global IOPS team to align on quality standards and procedures.
- Oversee the product release process, which includes managing shipments, changes, and deviations.
- Establish and maintain contracts with manufacturers to ensure quality compliance.
- Respond to quality complaints and prepare investigation reports and corrective action plans (CAPAs).
- Prepare for and manage inspections conducted by administrative authorities.
- Maintain the GQP/GMP documentation system, including updating SOPs and global procedural documents.

■Additional details:
- 3 steps interview, including one face-to-face in the client's office
- Stock option available on top of base + bonus compensation
- Workstyle 3 days from office/week
- Reports directly to the Hinseki, and will supervise one Quality Operation specialist

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

#LI-Hybrid
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こんな方を求めています

経験・スキル

■Required Qualifications:
- A university degree or higher in a science-related field.
- A minimum of 7 years of experience as a QA Manager in GQP within the pharmaceutical industry.
- Advanced knowledge and skills related to quality assurance, quality control, and manufacturing control.
- Business-level proficiency in English.
- A pharmacist license or experience supporting GDP operations for wholesalers and transporters is considered a plus.

学歴

大学卒業以上

募集要項

職種

品質保証/品質管理

給与

年収 1,100 〜 1,600万円

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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