Manager, Country QA Innovation and Compliance

9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.

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. Digital innovation and Data Science
 Lead project related to Digital innovation in Japan
 Process Improvement
 Japan representative for Project led by Global lead
3. 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.

ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。
約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。
ノバルティスファーマ株式会社は、スイス・バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。https://www.novartis.co.jp