Associate Director Biomedical Research Clinical Quality
Novartis
Toranomon, Tokyo, JP
Quality oversight of clinical trials
Health authorities compliance
Quality risk management
Provide strategic Quality oversight on the entire Clinical Trial Process to ensure compliance with Health Authorities requirements and patient safety
Job Summary
Provide strategic Quality oversight on the entire Clinical Trial Process to ensure compliance with Health Authorities requirements and patient safety.
Drive a culture of quality in NIBR by close business partnering and implementing the quality strategy.
Novartis empowers employees to explore digital and data innovations and encourages taking smart risks to tackle the world’s toughest medical challenges.
Matching Summary
Provide strategic Quality oversight on the entire Clinical Trial Process to ensure compliance with Health Authorities requirements and patient safety.
Skills & Requirements
Must-have
Quality oversight of clinical trials
Health Authorities compliance
Quality risk management
Clinical development expertise
GCP and quality assurance
Project management experience
Audit and inspection readiness
Nice-to-have
Strong interpersonal skills
Negotiation and problem solving
Business partnering
Continuous improvement initiatives
Analytical development
Technological expertise
Self-awareness
Key Requirements
Degree in Life Sciences, Pharmacy or Medicines
7+ years in regulated activities (GCP/PV) and clinical development
3+ years project management experience
Fluency in English
Ability to work independently in a global matrix environment