Interpret external regulatory standards and expectations into appropriate quality standards and provide mentorship to project teams or functions to ensure overall compliance with AstraZeneca and Regulatory requirements are met.

Provide QA input into internal manufacturing activities for Drug Substance and Drug Product, including issuance of batch documentation and labels for GMP manufacture/packaging, support of on-the-floor manufacturing activities, and support of manufacturing and packaging deviations and investigations.

Lead continuous and quality improvement efforts in line with GMP regulations via tracking and trending of site metrics.

Support activities associated with QA release of Drug Substance, Drug Product, and Investigational Medicinal Product for clinical trials, including quality review of release documentation for completeness and compliance with cGMPs as per regulatory requirements and internal p...