Director of Quality Assurance Partnerships
5 days ago
We are seeking an experienced professional to lead our External Service Provider (ESP) partnerships. As Associate Director, you will be responsible for ensuring that our partners meet the highest standards of excellence in supporting Novartis Global Clinical Trials.
Your key responsibilities will include:
- Review and approval of ESP qualification for global clinical trials
- Negotiation and execution of Quality Assurance Agreements (QAA) / quality terms with ESPs
- Review and approval of external service provider Quality Risk Assessments (QRAs)
- Communication and support mitigation of actions for potential risks
- Review and approval of quality issues related to ESPs
You will work closely with business partners such as Vendor Partnership and Governance, Global Medical Affairs, and Procurement to ensure their involvement in the risk evaluation and timely communication to the business.
About YouTo be successful in this role, you will need:
- A bachelor's degree in Life Sciences, Pharmacy or Medicine, or other related discipline
- 12+ years' experience in pharmaceutical development and excellent knowledge of the quality management system, clinical operations processes, and vendor management related activities
- Good knowledge of GCP/GLP, GMP, GVP
- Demonstrated leadership in implementing robust processes and quality systems
You should also have experience in managing External Service Providers and knowledge of quality standards and regulatory requirements.
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