Feb 26, 2024

About the Role

Country QA Complianceは、品質統括部門の中でも、GMP適合性調査業務を主に行う部署です。本Roleでは、新規申請、一変申請に伴うGMP適合性調査、及び5年ごとに実施する定期GMP適当性調査につき、申請~結果通知受領までの当局対応を行います。主に海外及び篠山工場等の国内製造所とのコミュニケーションを通して申請に必要な情報を入手し、各調査権者への申請及び照会対応等を行います。また、GMP適合性調査以外の業務として、開発プロジェクトへの参画があります。薬事部門や国内外の製造所、サプライグループと協働しながら、新薬発売に貢献することができます。GMP適合性調査業務の経験のある方、新薬の申請から市販後の品質管理業務に関する知識・経験の幅を広げたい方、新たなキャリアとしてQA業務に挑戦してみたい方からの応募をお待ちしています!

Job Purpose:
Based on Novartis Quality Manual and Policies, the following are achieved under local regulations for Innovative Medicines
• Maintain regulatory compliance under GxP/QMS and related local regulations
• Stable supply to high quality products
• Satisfy customers from quality point of view

Major Accountabilities:
1. Compliance
 Regulatory Compliance
 PMDA GMP Compliance Inspection (Paper based / On-site inspection)
 Lead local task/initiative to maintain compliance to new local regulation including Pharmacopoeia update

2. Cross-functional support & Stakeholder management
 NPI (New product Introduction)
 BD&L (Business Development & Licensing) Project
Support of Routine Quality Operation

Why consider Novartis?

817million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.


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.
健康状態や障害を理由に採用プロセスのいかなる部分においても、あるいは職務の必須事項を果たすために合理的配慮が必要な場合は [email protected]宛てに電子メールをお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してください。

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Role Requirements


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

Full Time
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Associate, Country QA Compliance

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