摘要
Are you passionate about shaping quality systems that drive excellence and compliance? As the Manager, Country QA QMS, you’ll play a pivotal role in ensuring Novartis Japan meets both regulatory and internal quality standards. You’ll lead the implementation of robust quality processes, foster a culture of continuous improvement, and collaborate across divisions to elevate operational efficiency. This is your opportunity to make a meaningful impact on patient safety and product quality while working in a dynamic, cross-functional environment.
品質システムの構築と運用に情熱をお持ちですか？Manager, Country QA QMSとして、Novartis Japanが規制要件および社内品質基準を確実に満たすための重要な役割を担っていただきます。堅牢な品質プロセスの導入をリードし、継続的改善の文化を醸成し、部門横断的な連携を通じて業務効率を高めていただきます。患者の安全性と製品品質に直接貢献できる、やりがいのあるポジションです。
About the Role
Key Responsibilities:
- Champion a consistent quality culture across Novartis Country Quality Japan.
- Lead implementation of quality systems with focus on compliance and operational efficiency.
- Drive operational excellence aligned with global process streams and country strategy.
- Monitor key quality indicators to ensure process control and regulatory compliance.
- Oversee quality governance for third-party vendors and outsourced activities.
- Ensure readiness and follow-up for regulatory inspections and compliance remediation.
Requirements:
- Degree in Life Sciences, Pharmacy, or Medicine. Pharmacist license is a plus
- Minimum 5 years of Quality Assurance experience in the pharmaceutical industry.
- Proven leadership in managing compliance-related projects or organizations.
- Strong understanding of GQP, GMP, GDP, and PV regulatory frameworks.
- Excellent communication, negotiation, and problem-solving skills.
- Fluency in English and Japanese (oral and written)
主な役割責任
- Novartis Country Quality Japan全体で一貫した品質文化の推進
- コンプライアンスと業務効率に重点を置いた品質システムの導入
- グローバルプロセスと国の戦略に沿った業務改善の推進
- プロセス管理と規制遵守を確保するための主要品質指標の監視
- 外部委託業務およびベンダーに対する品質ガバナンスの実施
- 規制当局の査察対応および是正措置の準備・実施
応募要件
- ライフサイエンス、薬学、医学の修士/学士号 （薬剤師資格をお持ちの方歓迎）
- 製薬業界での品質保証業務経験５年以上
- コンプライアンス関連プロジェクトまたは組織のリーダー経験
- GQP、GMP、GDP、PVなどの規制枠組みに関する深い理解
- 優れたコミュニケーション、交渉、問題解決スキル
- 英語/日本語での読み書き・会話が堪能であること
Benefits and Rewards:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
novartis-life-handbook.pdf
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to midcareer-r.japan@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.