AstraZeneca

The Clinical Quality Manager (CQM)/Senior CQM is responsible for providing direction and advice on how to use the business processes and existing systems to R&D China Development Operations (DevOps) team to enable the delivery of drug and non-drug projects according to agreed high quality standards and processes toward the goal of inspection-ready.

The CQM provides compliance and process advice to DevOps team and identifies opportunities for quality and process improvements on local and global level. 

The CQM is responsible for the development, implementation and continuous review of local procedural documents, and maintains current knowledge and understanding of local regulations and industry practices in relation to clinical trials.

The CQM supports audits, self-verification, inspection readiness and inspections and is the main contact for auditors for the DevOps team.

The CQM supports the DevOps leadership team in the planning and implementation of all quality control activities and uses risk management to evaluate compliance issues and develop solutions. The CQM keeps abreast of any business compliance issues and works in close collaboration with DevOps leadership and any key local and global networks.

The CQM requires anticipating and addressing major vendor quality and compliance issues with internal stakeholders (i.e. DevOps, QA, Legal, Procurement, and Finance) and our alliance partners.

A CQM may take on additional responsibilities or other roles such as study manager or line manager, or key global/local assignments as agreed with DevOps Leadership.

CQMs might have different internal titles based on the experience level (CQM, Senior CQM). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Clinical Quality Associate Director may assign this internal title after confirmation with Head of Development Operations R&D China.

Typical Accountabilities

• Provides advice to DevOps staff on AZ procedural framework including global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and on international guidelines such as ICH-GCP, industry standards and local regulations.
• Coordinates the development, publication, training, implementation, maintenance and archiving of Local Procedural Documents, ensuring compliance with global Clinical Procedural Documents, applicable Quality & Compliance Manual documents, international guidelines such as ICH-GCP and local regulations.
• Supports local management in the planning and conduct of local quality control activities, including performing accompanied site visits, in-house quality checks with local staff and provides local management with information regarding status of quality observed in DevOps.
• Supports the local organisation in the preparation for, conduct of and responses to audits, self-verification, inspection readiness and regulatory inspections. Advises DevOps staff on the resolution of the findings in audit and inspection reports. Gives regular feedback on audit and inspection findings to relevant DevOps staff.
• Identifies and organises/provides on-going and ad hoc training of local staff according to local training needs, in cooperation with DevOps leadership:
• Introductory training to new staff, including Procedural Training.
• Ad hoc local training solutions: e.g. as result of serious or recurring quality issues.
• Is involved in other local initiatives to identify and share best practices.
• Ensures function level vendor quality and compliance control in DevOps R&D China to fit with DevOps R&D China's strategies, objectives, and goals.
• Participates and contributes to the Clinical Quality Managers’ Network and involves in local regulatory or operational external experts’ groups, as required on country level.

【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

26-12月-2023

Closing Date

29-6月-2024

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.