(Sr.) Clinical Quality Manager job opportunity at AstraZeneca.

Home Jobs In China Tag: Job (Sr.) Clinical Quality Manager position at AstraZeneca


DateMore Than 30 Days Ago bot
AstraZeneca (Sr.) Clinical Quality Manager
Experience: 6-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeOND
loacation Shanghai Jing'An Office, China
loacation Shanghai Jing'..........China

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 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 Essential 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. G ood 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. Desirable 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. 【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 22-12月-2025 Closing Date 30-3月-2026 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.

Other Ai Matches

Corporate Affairs Generalist – Global Corporate Affairs Applicants are expected to have a solid experience in handling Job related tasks
Finance Intern in Commercial FP&A Team - 12 months Career Starter Program Applicants are expected to have a solid experience in handling Job related tasks
Senior Study Start-up Manager Applicants are expected to have a solid experience in handling Job related tasks
Medical Sales Representative – Respiratory – (South East Hungary) Applicants are expected to have a solid experience in handling Job related tasks
Stage Visiteur Médical IDF (H/F) Applicants are expected to have a solid experience in handling Job related tasks
Key Account Manager CVRM - Timisoara Applicants are expected to have a solid experience in handling Job related tasks
DSM-Hema-杭州 Applicants are expected to have a solid experience in handling Job related tasks
Sr. Pharmaceutical Sales Specialist, Specialty Care Respiratory Biologics-Puerto Rico Applicants are expected to have a solid experience in handling Specialty Care Respiratory Biologics-Puerto Rico related tasks
MR-HEMA-徐州 Applicants are expected to have a solid experience in handling Job related tasks
Principal Enterprise Architect Commercial OBU Applicants are expected to have a solid experience in handling Job related tasks
SAP Business Partner Applicants are expected to have a solid experience in handling Job related tasks
Senior Director Physician, Cardiovascular Safety Knowledge Group Expert, AZ ECG Centre Cardiologist Applicants are expected to have a solid experience in handling Cardiovascular Safety Knowledge Group Expert, AZ ECG Centre Cardiologist related tasks
Senior Manager/Associate Director-Marketing (Neuro TA) Applicants are expected to have a solid experience in handling Job related tasks
Senior Data Programmer CPQP Programming (PKPD / Pharmacometrics / NONMEM / SAS Programmer) Applicants are expected to have a solid experience in handling Job related tasks
District Business Manager (For Pooling) Applicants are expected to have a solid experience in handling Job related tasks
Director, Process Safety and SIF (Serious Injury & Fatality) Prevention Applicants are expected to have a solid experience in handling Process Safety and SIF (Serious Injury & Fatality) Prevention related tasks
Marketing Lead - Oncology - Breast Applicants are expected to have a solid experience in handling Job related tasks
Compliance Director – Regional Assurance Lead – China Applicants are expected to have a solid experience in handling Job related tasks
Key Account Manager Oncology - Lung Cancer - Moravia Applicants are expected to have a solid experience in handling Job related tasks
Senior Manager, Commercial, GBS Process & Analytics Services Applicants are expected to have a solid experience in handling Commercial, GBS Process & Analytics Services related tasks
MR-HEMA-南京 Applicants are expected to have a solid experience in handling Job related tasks
Pharmaceutical Sales Specialist, R&I Primary Care - Glendale South, AZ Applicants are expected to have a solid experience in handling R&I Primary Care - Glendale South, AZ related tasks
District Business Manager - Cebu, Bohol and Dumaguete Applicants are expected to have a solid experience in handling Bohol and Dumaguete related tasks