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Job Description:
About the Role:
- Ensure high-quality, compliant analytical testing across global GxP labs (internal and external).
- Oversee method development, validation, release, and stability testing for multiple modalities.
- Champion data integrity and strong quality systems in all laboratory activities.
- Partner with cross-functional teams to support analytical lifecycle and submissions (IND/CTA/NDA/BLA).
- Lead or support laboratory related investigations and inspections key quality initiatives and investigations that directly impact patients and products.
- グローバルな GxP 試験検査室(社内および外部委託)における、高品質でコンプライアンスに準拠した分析試験を確実に実施する。
- 複数モダリティを対象とした分析法の開発、バリデーション、製品出荷試験および安定性試験を統括する。
- すべての試験検査室活動において、データインテグリティと堅牢な品質システムを推進する。
- 分析ライフサイクルおよび申請(IND/CTA/NDA/BLA)を支援するため、部門横断のチームと連携する。
- 試験検査室に関連する調査および査察をリードまたはサポートする。
What You'll Do:
- Provide quality oversight for GxP and non-GxP labs across the R&D pipeline.
- Review and approve critical GMP/GLP documentation (methods, validations, deviations, CAPAs).
- Ensure robust ALCOA+ data integrity controls in lab systems, processes, and records.
- Lead or support lab-related investigations, audits, and inspections with clear, timely CAPA.
- Collaborate with Pharmaceutical Sciences, Regulatory, Manufacturing, and QA to align on quality expectations.
- 研究開発パイプライン全体を通じて、GxP および非 GxP 試験検査室に対する品質オーバーサイトを提供する。
- 重要な GMP/GLP 文書(分析法、バリデーション、逸脱、CAPA など)をレビューし、承認する。
- 試験検査システム、プロセスおよび記録において、ALCOA+ に基づく堅牢なデータインテグリティ管理を確保する。
- 試験検査室に関連する調査、監査および査察をリードまたはサポートし、明確かつタイムリーな CAPA を実行する。
- ファーマシューティカルサイエンス、薬事、製造、品質保証(QA)と連携し、品質に関する期待値を整合させる。
What You Bring:
- Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or related field; MS/PhD preferred.
- 7+ years' experience in GxP laboratory quality oversight (GMP/GLP, analytical testing, inspections).
- Strong knowledge of analytical methods and lab operations for small molecules and biologics (other modalities a plus).
- Proven skills in data integrity, deviation/CAPA management, and quality risk management.
- Clear communicator and collaborator, effective in a global matrix environment with competing priorities.
- 理系学士号(ライフサイエンス、化学、バイオケミストリー、または関連分野)を有すること。修士号/博士号尚可。
- GxP 試験検査室の品質オーバーサイト(GMP/GLP、分析試験、査察対応など)において 7 年以上の経験を有すること。
- 低分子およびバイオ医薬品(その他のモダリティであれば尚可)の分析法および試験検査室オペレーションに関する高い知識を有すること。
- データインテグリティ、逸脱/CAPA マネジメント、および品質リスクマネジメントに関する実績のあるスキルを有すること。
- 明確なコミュニケーション能力と協働能力を備え、優先順位が競合するグローバルなマトリクス環境で効果的に業務を遂行できること。
Takeda Compensation and Benefits Summary:
- Allowances Commutation, Housing, Overtime Work etc.
- Salary Increase Annually, Bonus Payment Twice a year
- Working Hours Headquarters (Osaka/ Tokyo , Production Sites (Osaka/ Yamaguchi , (Narita , Research Site (Kanagawa
- Holidays Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)
- Paid Leaves Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.
- Flexible Work Styles Flextime, Telework
- Benefits Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.
Important Notice concerning working conditions:
- It is possible the job scope may change at the company's discretion.
- It is possible the department and workplace may change at the company's discretion.
Locations:
JPN - Kanagawa - Remote
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
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