The main purpose with the role is to ensure AZ China Medical Affairs (CMA) Evidence Generation adhere to external and internal regulatory requirements, e.g. the requirements of ICH GCP, GVP, China GCP, relevant Chinese regulations and AZ SOPs in conducting clinical trials and pharmacovigilance.

The Quality Control position is responsible for leading QC team to delivery responsibilities as QC plan defined, and completing other emergency tasks as required.

This role should understand company’s compliance & SHE policy, and to manage the daily activity to align with these accordingly.

DUTIES & RESPONSIBILITES / 主 要 职 责

Lead Continuous Improvement In Quality of China MA led Clinical Studies

• Lead the development and execution of annual QC plan which is agreed with China EvGen Head;
• Identify any compliance gap in local process for clinical trial;
• Drive the development, implementation and maintenance of local procedural documents for clinical studies;
• Lead team to improve quality management, including risk management, change management, issue management, etc.;
• Lead team to develop and/or optimize study plans to ensure study tools can meet requirements for clinical trial development;
• Maintain clinical study agreement (CSA) templates to ensure CSA templates updated and meet requirements for both AZ sponsored study and ESR;
• Ensure CMA EvGen is ready for audit and inspection at any time;
• Provide advice on Corrective actions and preventive actions (CAPA) for QC/audit/ inspection findings;
• Lead study team to conduct root cause analysis on all significant audit / inspection findings;
• Identify opportunities for quality improvement and optimizing/simplifying elevant processes

Support clinical study

• Lead team to conduct on-site QC for AZ sponsored studies;
• Lead team to conduct eTMF QC for AZ sponsored studies;
• Lead team to conduct QC for AZ sponsored studies;
• Lead team to conduct sampling check for PM ASV reports and CRA monitoring reports;
• Conduct QC for SUSAR line listing monthly;
• Conduct ESR 1st Line monitoring;
• Perform ESR Bulletin Oversight;

Audit/Inspection

• Lead audit &Inspection’s readiness;
• Primary local point of contact for Quality Assurance and Regulatory Agency
• Manage and coordinate activities during the preparation/ongoing/follow up phase of an audit or inspection;

Vendor Management

• Support EvGen Head to assess ODD requirement;
• Coordinate external ODD vendor to conduct ODD;
• Follow up ODD finding and CAPA;
• Participate in vendor KPI management, e.g., issue resolution, as needed;

Training

• Develop NEO training matrix and routine training matrix aligned with Head of Evidence Generation, CMA;
• Ensure trainings can be delivered to study teams as needed;
• Ensure learning from QC checking, audit and inspection for study teams which is aimed at increasing study team capability to deliver qualified study EvGen activities;
• Organize external training/workshop, as needed;

Quality management meeting

• Attend MAH & GxP meeting periodically;
• Take actions as needed;

Others

• Complete other tasks assigned by Line Manager;

(a) Key working relationships / 主 要 工 作 关 系

• Internal contacts within AZ / 内 部 联 系

Global & Regional

• Quality & Compliance from GMA;
• QA from R&D;
• Procedural & Process Management Network

Local

• Head of Evidence Generation, China MA
• Local Study Team Leaders and Local Study Team Members – Evidence Generation, China MA
• GxP QMS, China MA
• Pharmacovigilance Personnel, China MA
• Medical Excellence Manager, China MA
• QC team, R&D China

• External contacts with organizations outside AZ / 外 界 联 系

• Study team staff of Contract Research Organization
• Study site staff
• External Service Provider for AZ PV
• Health authorities

(b) Job requirements /工 作 要 求

• Results Driven Behavior
• Self-motivation and adaptability
• Experience in clinical quality management in pharmaceutical industry
• Ability to form strong alliances with marketing teams and among own team members

(c) Academic / Professional qualification / 学 历 / 专 业 资 格

• Bachelor degree or above of medical/pharmaceutical specialty
• Proven experience of the execution of clinical quality management

(d) Technical/skill training / 技 术 / 技 能 训 练

• strong interpersonal skills, with the ability to work effectively with stakeholders at all levels
• Excellent competence of GCP/GVP and clinical study procedure or pharmacovigilance
• Good presentation skills
• Proven ability to deliver training
• Familiar with budgeting

(e) Working experience (No. of years / 年 资, Job function / 工 作 功 能, Business types / 业 务 种 类 )

i) Essential 必 需

• At least 5-year working experience in relevant for a multinational pharmaceutical company
• At least 1-2 years as Associate QC Mgr. or equivalent
• 1-2 years proven training or coaching experience
• Procedural documents generating experience

ii) Desirable 理 想

• Prior experience not only as a clinical management/PV specialist/PV physician staff, but responsible for quality assurance/ quality control/ procedural document developing
• Experience in working in international and cross functional teams
• Experience in line management if role also includes line management responsibilities
• AZ experience

Language ability / 语 言 能 力

• Fluent oral and written English is essential, to own second language is a preferable plus

Computer literacy / 电 脑 知 识

• Good command of Microsoft Office skills

【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

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.