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. Lead trend analysis and lessons learned sharing on audit and inspection findings to relevant Cell Therapy Clinical Operation staff.

·       Lead local training platform and/or training programs from design to execution and drive continuous optimisation.

·       Lead Cell Therapy Clinical Operation 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

Essential

·       Bachelor’s degree in healthcare-related field, or equivalent.

·       At least 8 years experience in Clinical Operations or other related fields, including 4 years experience in clinical quality management.

·       Solid knowledge and experience in China GCP inspections and deep understanding of GCP.

·       Adequate knowledge of Study Management, site management & monitoring, and local regulations.

·       Fluent spoken and written English.

·       Excellent skills to drive clinical process development and optimization.

·       Excellent Training Skills

·       Strong leadership to drive cross functional projects/initiatives.

·       Rapid learning and flexibility, high sense of responsibility and strong results orientation.

Desirable

·       Strategic thinking and has foresight capability.

·       Risk and crisis management skills.

·       Manages change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.