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External Service Provider Quality Assurance Manager
1 week ago
This role offers an exciting opportunity to oversee the implementation of top-notch quality standards, cutting-edge processes, and innovative tools and systems. As Associate Director External Service Provider QA, you will play a pivotal role in managing external service providers supporting Novartis Global Clinical Trials in R&D Quality, ensuring that our partners meet the highest standards of excellence.
Key Responsibilities:- Responsible for review and approval of External Service Providers (ESP) qualification for global clinical trials.
- Negotiate and execute Quality Assurance Agreements (QAA) / quality terms with ESPs.
- Review and approve external service provider Quality Risk Assessments (QRAs) to identify potential quality and performance issues.
- Collaborate with business partners to ensure involvement in risk evaluation and timely communication.
- Bachelor's degree in Life Sciences, Pharmacy or Medicine, or related discipline.
- 12+ years' experience in pharmaceutical development and knowledge of quality management systems.
- Good knowledge of GCP/GLP, GMP, GVP.
- Demonstrated leadership in implementing robust processes and quality systems.
