(Sr.) Clinical Quality Manager at AstraZeneca

Daxing District, Beijing, China -

Full Time

Start Date

Immediate

Expiry Date

22 Mar, 26

Salary

0.0

Posted On

22 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Quality Management, GCP, Quality Compliance, Data Privacy, Cross Border Data Transfer, Trend Analysis, Training Development, Audit Strategy, Communication, Leadership, Process Optimization, Regulatory Knowledge, DevOps, Healthcare, Risk Management, Change Management

Industry

Pharmaceutical Manufacturing

Description

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. 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. 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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Clinical Quality Manager is responsible for leading quality management activities and ensuring compliance with quality standards for drug and non-drug projects. This includes advising staff on procedural frameworks, conducting audits, and driving continuous optimization of quality management processes.