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 AstraZenecas 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QAEQ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

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.