職位描述
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 DevOps. * 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 DevOps 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 DevOps contact with QA to design audit strategy to DevOps relevant activities and coordinate the audit conduct with study teams. Act as quality expert to advise DevOps staff on the resolution of the findings in audit and inspection reports. Lead trend analysis and lessons learned sharing on audit and inspection findings to relevant DevOps staff. * Lead local training platform and/or training programs from design to execution and drive continuous optimisation. * Lead DevOps clinical compliance management relevant activities, such as data privacy and cross boarder data transfer relevant assessment and contribute to process review to ensure business compliance with China local regulations.Education, Qualifications, Skills and Experience: * Bachelor’s degree in healthcare-related field, or equivalent. * At least 6 years experience in Clinical Operations or other related fields, including 2 years experience in clinical quality management or equivalent. * Solid knowledge and experience in China GCP inspections and deep understanding of GCP. * Good knowledge of Study Management, site management & monitoring, and local regulations. * Fluent spoken and written English. * Ability to look for and drive more efficient and effective methods/processes of delivering quality management activities. * Good communication and leadership to drive cross functional projects/initiatives. * Rapid learning and flexibility, high sense of responsibility and strong results orientation.
