- 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.
- Bachelor's degree in healthcare-related field, or equivalent.
- At least 6 years experience in R&D 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.
- Risk and issue 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.
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Clinical Quality Manager - Jing'An, 中国 - AstraZeneca
描述
The Clinical Quality Manager (CQM) is responsible for providing quality and compliance advice as well as planning and implementing quality management activities to enable the delivery of drug and non-drug projects, according to agreed quality standards toward the goal of always inspection ready.
Typical Accountabilities
Education, Qualifications, Skills and Experience
Essential
Desirable
【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. 阿斯利康是一家提供平等机会的企业,我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份(如果适用)及任何其他受法律保护的特征而产生歧视。】
Date Posted
20-2月-2024Closing Date
30-3月-2024
