Associate Director Biomedical Research Clinical Quality

Job Description Summary

Provide strategic Quality oversight on the entire Clinical Trial Process (CTP) for the clinical trials under responsibility in order to ensure compliance with the Health Authorities requirements, the internal standards and a full adherence to patients’ safety, rights and well-being.
Provides risk analysis to internal stakeholders to make critical decisions.
Dispense QA expertise and guidance to Translational Medicine and Translational Clinical Oncology and collaborate with other QA functions in order to ensure that high priority programs, Quality initiatives driven by the business meet defined expectations.

Takes full ownership of the quality aspects of the assigned clinical trials

Lead/ participate in due diligence efforts for assigned programs.

Drive a culture of quality in NIBR by close business partnering to positively impact the business and implementing the quality strategy.

 

Job Description

Major Activities ：

• Proactively provide QA leadership for assigned franchise by ensuring considerable organization awareness (e.g. Interrelationship of departments and business priorities).

• Support implementation of quality strategy under the responsibility of Translational Medicine or Translational Clinical Oncology.

• Regularly monitor the implementation of the annual Quality Plan pertaining to the Clinical chapter and ensure that all delayed activities have a documented rational and appropriate escalation.

• Ensure adequate oversight of proactive quality risk management process in the overseen areas including quality risk assessments and submission/inspection readiness activities and ensure that Clinical Trial Processes are in control.

• Provide robust and clear quality oversight in the following areas of clinical development:

• Actively leverage audit/inspection outcomes/trends to sustain improvement in clinical trials conduct.

• Support continuous improvement initiatives and ensure that areas identified as weaknesses are properly being addressed and executed for sustainability

• Be QA point of contact for the assigned franchise and ensure quality is embedded in the decision taking processes.

Education(minimum/desirable):

Degree in Life Sciences, Pharmacy or Medicines. Advanced degree a plus.

Languages:

Fluency in English (oral and written)

Experience/Professional requirement:

• +7 years of involvement in regulated activities (GCP/PV), clinical development and/or QA positions.

• Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product development.

• Ability to work independently and in a global/matrix environment.

• 3 or more years’ experience in managing projects.

• Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.

• Strong skills in GCP, quality and/or clinical development.

• Strong interpersonal, communication, negotiation, and problem solving skills.

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

Japan
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.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.
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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 midcareer-r.japan@novartis.com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。

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現在の求人情報はすべてこちらに掲載されています。詐欺の可能性がある求人広告や採用オファーに遭遇した場合は、返信したり、金銭や個人情報を送ったりしないよう強くおすすめします。

 

Skills Desired

Agility, Analytical Development, Auditing, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Risk Management, Root Cause Analysis (RCA), Self-Awareness, Six Sigma, Sop (Standard Operating Procedure), Technological Expertise