Summary
Country QA Complianceは、品質統括部門の中で新製品開発への参画と、製造所に関するGMP適合性調査を担当する部署です。本Roleでは、新製品開発プロジェクトの一員として、薬事部門、国内外の製造所、サプライグループなどと連携しながら、新薬の発売に貢献できます。
GMP適合性調査業務においては、新規申請・一変申請に伴う調査、ならびに5年ごとに実施する定期調査における、申請から結果通知の受領までの当局対応を行います。海外製造所や、グループ会社である篠山工場を含む国内製造所とのコミュニケーションを通じ、申請に必要な資料の入手・確認、当局への申請および照会対応を担います。
新薬申請から市販後の品質管理まで、知識と経験の幅を広げたい方、GMP適合性調査の経験をお持ちの方、あるいはQA業務に新たに挑戦したい方からのご応募をお待ちしています
This position offers an exceptional opportunity for individuals who want to expand their expertise while taking on new challenges in the pharmaceutical quality field. By contributing to new product development projects and collaborating with a wide range of internal and external stakeholders, you will build cross-functional experience across quality, regulatory, and manufacturing domains. Through regular communication with domestic and global manufacturing sites as well as health authorities, you will broaden your perspective and strengthen your professional impact. As a key member supporting the launch of new medicines, you will play a central role in securing high-quality products for patients while continuously elevating your technical proficiency.
Country QA Compliance is a department within the Quality organization responsible for participating in new product development and conducting Good Manufacturing Practice (GMP) compliance activities related to manufacturing sites. In this role, you will contribute to new product launches by working closely with regulatory affairs, domestic and global manufacturing sites, and supply teams. For GMP compliance activities, you will lead end-to-end processes for new registration applications, post-approval variations, and periodic GMP inspections conducted every five years—including preparation, submission, communication with authorities, and coordination with manufacturing sites in Japan and overseas. Through this role, you will gain broad exposure from new drug applications to post-marketing quality management.
We welcome applicants with experience in GMP inspections, those eager to expand their quality knowledge, and those motivated to take on new challenges within Quality Assurance.
About the Role
Key Responsibilities
- Lead regulatory compliance activities aligned with both Japan and global quality standards
- Prepare documentation and manage end-to-end activities for GMP compliance inspections conducted by PMDA
- Collaborate with cross-functional teams to support new product introduction from a quality perspective
- Support daily quality operations to ensure consistent processes and sustainable quality performance
Essential Requirements
- Bachelor’s degree or higher, or equivalent academic background
- Minimum three years of experience in pharmaceutical quality-related roles
- Experience with new product registration or GMP compliance inspections is an advantage
- Native-level Japanese proficiency and business-level communication skills in English (spoken and written)
- Strong organizational and coordination skills to manage multiple tasks collaboratively across functions
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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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
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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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
