Senior Clinical Quality Manager

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From AstraZeneca’s original posting

Typical Accountabilities • Lead the design and implementation on assigned local quality management activities, including performing accompanied site visits, in-house quality checks and provide local management team with quality metrics and dashboard in Cell Therapy Clinical Operation. • Provide advice to DevOps staff on AZ procedural framework including local clinical procedural documents, applicable Quality & Compliance manual documents, and on international guidelines such as ICH-GCP, industry standards and local regulations. Drive the continuous optimization of CQM helpdesk to support Cell Therapy Clinical Operation colleagues with quality and efficiency.· Drive the development, publication, training, implementation, maintenance and archiving of Local Procedural Documents, ensuring compliance with global Clinical Procedural Documents management requirements. · Act as Cell Therapy Clinical Operation contact with QA to design audit strategy to Cell Therapy Clinical Operation relevant activities and coordinate the audit conduct with study teams. Act as quality expert to advise Cell Therapy Clinical Operation staff on the resolution of the findings in audit and inspection reports.…