342910BR
Apr 18, 2022
Japan

Job Description

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.
We are transforming to become an agile quality organization by establishing reliable & robust Quality System for supplying innovative and life-changing medicines to our patients.

-Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.
-Prepare, review and check the batch documentation for correctness, completeness and safely archive the original documents for the prescribed period and plan, conduct and monitor self
-Inspection schemes for all sections. Monitor actions and corrections accordingly.
-Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, follow up the corrective actions. Archive relative documentations and manage/Approve critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed. Ensure all required actions are taken appropriately and in a timely fashion. -Escalate any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required. Decide escalation to Senior Management Level and lead Global Quality Assessments and manage filing accordingly as well as ensure that Change requests, are managed according to the Novartis SOPs from receipt, through to the implementation and closure.
-Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance and maintain access to regulatory and Pharmaceutical authorities in respect to up-dated GxP ovide latest know how in the field of GxP and other quality related fields. Identify repetitive activities and regulatory areas for which SOPs are required. Initiate the introduction of SOPs.
-Plan, initiate and monitor basic GxP-training for all employees in regular intervals. Be responsible for annually training program and implementation. -Establish and maintain cross-functional contacts with peer organization and authorities and, follow-up quality related developments in the field of Pharmaceutical products
-Support launches of product in close collaboration with BD& L partner and/ or development organization.
-Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations.
-Ensure that coordinated contact is maintained with all part



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

Diversity & Inclusion / EEO

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

Minimum Requirements

3-4 years relevant experience Japanese Bachelor or equivalent in scientific area Preferable for knowledge of GDP and product supply management.

Key perfomance:
-Local GMP/GDP Quality System in place and continuously updated, asrequired -GMP/GDP risks proactively identified and effectively mitigated.

Minimum Requirements:
Operations Management and Execution Collaborating across boundaries Functional Breadth Participating in volunteer / community projects English Regulations & Guidelines Risk Management Product Release Quality Change Control Quality Management Quality Assurance
Novartis Technical Operations
NTO QUALITY
Japan
Tokyo
Quality
Full Time
Regular
No
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342910BR

Manager, Commercial GMP QA

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