Quality Associate Director, MCOQ
Core Accountabilities:
Develop, support and drive excellence in MCOQ GMP&GDP Quality activities to maintain the local License to Operate.
Participates in defining the strategy for the commercial global markets ownership and execution of MCOQ GMP and GDP Quality System and framework in country
Define, develop, deploy and monitor the GMP/GDP policies and standards and execution in country markets
Supports local MC to deliver the license to operate, including but not limited to support for GMP&GDP/GSP audits and inspections, implementation effective self-inspection programs in the country of responsibility.
Responsible for ensuring QMS compliance and continuous improvement in the Region and all issues are managed and closed on time, risks are identified and escalated to Global Quality.
Represents Quality on cross-functional and cross SET teams and steering committees related to MC market
Drive global standardisation, simplification, and improvement of MCOQ Quality business processes. Develops and sustains a high-quality organisation that delivers against global processes, and aims to continuously improve in competence, compliance standards and innovative delivery of results.
Provide training, supporting and coaching structure for Quality MCOQ network roles
Participates in strategy and objectives setting for the MCOQ organisation
Accountable for compliance assurance and working to one set of GMP & GDP/GSP standards and processes, as well as common GxP process across the MC GxPs.
Accountable for both GSP regulatory and AZ standards related to distribution of AZ product in country, including but not limited to release of product batched, resolution of Issue Management, recalls, influence and decisions on local regulatory agency interactions, audits and inspection readiness and compliance to gain and maintain AZ licence to operate.
To be part of global vendor program management, support AZ finished products management and work with sending site QA, EQ and global cooperate quality.
Demonstrated ability to work independently and in project settings to deliver objectives.
Keeps own knowledge of best practices, industry standards and new developments in quality management up to date
Leads trouble shooting activities to resolve existing problems, make complicated judgements and anticipate future developments in AstraZeneca’s Quality related needs
Employs prepared information to discuss, plan and help carry out improvement plans, priority setting, investigation reports, quality or performance improvement recommendations
Carries out compliance reviews and reporting for external suppliers including issue resolution with senior management
Contribute to Quality function in developing quality management system to fulfil Good Supply Practice (GSP) and AstraZeneca standards to ensure continuous improvement.
Responsible for the assessment and implementation of regulatory and AZ policy & standards requirements.
For process and procedure impacted multiple areas, represent China MCOQ Quality to correspond with other function.
Promotes a Quality Culture in the MC sets strategy in the region and locally for execution of GMP/GDP excellence.
Responsible for the achievement of country KPIs and objectives/Quality Plans. Ensure country trends are addressed through development of country continuous improvement plans.
Contributes to development procedures in area of specialism and provides some technical input into the development of global standards for function and globally
Proactively looks for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring and appropriate level of compliance
在MCOQ的GMP与GDP质量活动中进行开发、支持并推动卓越表现，以维持本地药品批发企业的经营许可（License to Operate）。
参与制定商业全球市场在本国范围内对MCOQ的GMP与GDP质量体系及框架的所有权与执行策略。
定义、制定、部署并监控GMP/GDP流程、标准及其执行情况。
支持本地市场公司（MC）维持GSP证照维护，包括但不限于支持GMP/GDP/GSP审计与检查，以及在负责国家实施高效的自检计划。
负责确保区域层面的QMS合规与持续改进，确保所有问题按时管理与关闭，风险得到识别并上报至全球质量团队。
在与市场公司市场相关的跨职能、跨SET团队及指导委员会中代表质量职能。
推动MCOQ质量业务流程的全球标准化、简化与改进；构建并维持高质量组织，以落实全球流程，并持续提升能力、合规标准与创新性结果交付。
为质量MCOQ网络角色提供培训、支持与辅导机制。
参与MCOQ组织的战略与目标制定。
对合规保障负责，确保遵循统一的一套GMP与GDP/GSP标准与流程，以及在市场公司（MC）范围内的通用GxP流程。
对本国范围内AZ产品的配送活动中涉及的GSP法规与AZ标准负总责，包括但不限于产品批次放行、问题管理的解决、召回、与本地监管机构互动的影响与决策、审计与检查准备，以及确保合规以获取并维持AZ的经营许可。
参与全球供应商项目管理，支持AZ成品管理，并与发运生产地QA、EQ及全球公司质量团队合作。
具备在独立工作与项目环境中实现目标的能力。
持续更新个人在质量管理领域的最佳实践、行业标准与新发展方面的知识。
领导质量事件调查活动，以解决现有问题、进行复杂判断，并预判阿斯利康在质量相关需求的未来发展。
对外部供应商开展合规审查与报告，并就问题解决与高级管理层进行沟通。
为质量职能做出贡献，构建和完善质量管理体系，以满足良好供应规范（GSP）及阿斯利康（AstraZeneca）标准，确保持续改进。
负责监管要求与AZ政策/标准的评估与落实，确保符合适用法规与公司规范。
当流程与程序影响多个领域时，代表中国MCOQ质量团队与其他职能进行沟通与协作。
在市场公司中推动质量文化，并在区域及本地层面设定战略，以卓越执行GMP/GDP。
对国家级关键绩效指标（KPIs）、目标与质量计划的达成负责；通过制定国家层面的持续改进计划，确保及时应对国家趋势。
在专业领域参与制定相关程序，并为职能及全球范围的标准制定提供一定的技术意见。
主动识别变革与效率提升机会，在确保适当合规水平的同时影响决策并交付结果。
Education, Qualifications, Skills and Experience:
Licensed Pharmacist is mandated 执业药师（必须）
Degree or equivalent professional qualification in related field 大学本科及以上学历
8+ years’ experience in quality assurance within a GMP/GDP/GSP environment 8年以上药品GMP/GDP/GSP 质量管理经验
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 authorisation and employment eligibility verification requirements.
