Location
Cambridge, England, United Kingdom
Posted
July 22, 2026
Job Description
Job Description Summary
Job Description
Major accountabilities:
- Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. Manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations.
Job Description
Major accountabilities:
- Support maintenance of the regulatory-required files for health authority inspections and assist with health authority inspection management
- Support generation of Quality Plans (and review other plans for quality/safety aspects) for clinical programs
- Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management, health authority reporting, IT systems
- Support initiatives focused on quality, process and compli...