Quality Assurance Lead for Global Clinical Trials
6 days ago
We are seeking an experienced professional to lead the quality assurance efforts for external service providers supporting Novartis Global Clinical Trials in R&D Quality. The successful candidate will be responsible for ensuring that our partners meet the highest standards of excellence by reviewing and approving their qualification, negotiating quality assurance agreements, and identifying potential quality and performance issues.
The key accountabilities of this role include:
- Reviewing and approving the qualification of external service providers for global clinical trials.
- Negotiating and executing quality assurance agreements with external service providers.
- Collaborating with business partners to ensure timely communication and follow-up on required actions.
- Ensuring compliance with regulatory requirements (GCP, GLP, GVP, GMP) and continuous improvement of quality relevant processes within area of responsibility.
The ideal candidate will have a strong background in pharmaceutical development, excellent knowledge of the quality management system, clinical operations processes, and vendor management related activities. A bachelor's degree in Life Sciences, Pharmacy, or Medicine, or other related discipline is required. Fluency in English is essential, both written and spoken.
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