M&S-Country Quality Supervisor-Shanghai

Job description

Job title职位名称: Country Quality Supervisor Location工作地点： Shanghai 上海 About the job工作职责 We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main responsibilities职责描述： Management of the Country Quality Management System 分公司质量体系管理 Implement, manage, and control a Country Quality Management system for GxP activities from development to commercialisation of all products and related GxP services, in compliance with Sanofi requirements, as well as applicable local regulatory requirements. undefined Participate in the Oversee of all country GxP operation and compliance (including PV, regulatory, market supply chain, medical, etc.) through robust quality management system, to ensure fulfilment of post-market management , GSP/GDP quality management and MAHD accountability. undefined Understand Quality culture and promote Quality mindset into the country governance, working principles, and ways of operating. undefined Ensure appropriate communication of key messages pertaining to Quality across the country organization, highlighting their possible business impact. undefined Assure that a process for management of GxP documents and records is in use in all GxP areas, considering data integrity and data privacy principles. undefined Country Quality documentation system 本地质量文件系统： Organize a consistent life cycle management of Country GxP documents (except for Clinical Study Unit (CSU)) using the global content management system. undefined Ensure and coordinate across GxP functions the direct use of global documents or the creation of country GxP documents, based on the Advanced Content Template (ACT) in case of any regulatory requirement. undefined Country Quality audits and GxP regulatory country inspections 本地质量审计和GxP监管检查： Collaborate to ensure country inspection readiness. undefined Participate in the Management of country regulatory inspections related to GxP processes owned by the CQH and provide support and coordination with other GxP country functions in country regulatory inspections for processes in their respective areas of responsibilities, ensuring contribution of concerned functions at global level, as needed. undefined Where applicable, in accordance with local regulations and/or the expectations of local regulatory authorities, collaborate with the Regulatory Affairs, Pharmacovigilance, and other relevant functional departments to support regulatory inspections of marketing authorization holders, overseas sites, and MAHD(s). undefined Implement a strategy for local quality audits, based on Quality risk management criteria, of key local GxP service providers directly managed by the country, including the outsourced hybrid processes (non-GxP processes with GxP impact) with safety reporting components. undefined Personnel Qualification and Training 人员资质和培训： Organize information sharing, training sessions or programs related to processes under the responsibility of the CQH for concerned country associates, according to Sanofi and regulatory requirements. undefined Ensure that there are system, process and procedure in use for the personnel qualification (e.g. CV, job description, training curricula and records) and the management of GxP trainings across the country by each GxP function. undefined Country Quality Review分公司质量回顾： If required by local regulations, support the Annual Country Quality Review as per Sanofi requirements. undefined undefined undefined Deviation and CAPA management偏差和CAPA管理： Ensure that a process to timely manage deviations and CAPAs related to all GxP activities across the country is in use in a consistent manner. undefined Change Control management变更控制管理： Ensure that a process is in use across the country to manage proposed changes, that may impact GxP processes or operations, implementing risk assessment and action plans when necessary. undefined Country Quality Performance Indicators (KPI) 质量绩效指标（KPI）： Monitor MCO/country KPIs defined by Global Quality using the appropriate Global Quality computerised system. undefined Self-inspection自检/内审： Ensure compliance to the local requirements for self-inspection. undefined Implement a self-inspection process and program to meet regulatory requirement and enable continuous improvement and GxP inspection readiness. undefined Quality risk management质量风险管理： Ensure that quality risks are properly managed within the country (identification, assessment, control, communication). undefined Provide risk management expertise to other country functions as appropriate. undefined Non-product related quality events 非产品相关的质量事件： escalate and manage the events occurring at the country according to defined processes and procedures. undefined Computerized Systems (CS) and Digital Properties 计算机化系统（CS）和数字化工具： Maintain an up-to-date local inventory of GxP CS (exception for CSU) and digital properties and check if the locally owned GxP CS are validated as per Sanofi requirements and address any identified gaps accordingly. undefined Projects项目： Collaborate Quality projects. Provide Quality support to new business areas (e.g. acquisitions and divestments, products launch readiness) as needed. undefined Quality Intelligence质量情报： Implement a screening process for released local regulations to capture the requirements that must be transcribed into Country Quality documents. Ensure local process and system compliant with China GxP regulation through gap assessment and action taken if necessary. undefined Quality Communication质量沟通： Support quality culture relevant activities, e.g., World Quality Week, Greater China Quality Community to foster prosperous dialogue. undefined Quality Evolution 质量进化： Act as the local advocator to drive and support quality evolution in organization modernization and digitalization, by introducing mature digital tools into quality operation. undefined Product Quality 产品质量 Product Complaints产品投诉： Manage product complaints received from the markets including suspicious product cases (when applicable) in coordination with the central PTC organization, where applicable. undefined Conduct product complaints’ trend analysis and signal detection, as per Sanofi requirements and local regulations, if applicable. undefined Quality Inquiry质量问询： Manage quality inquiries received from the market according to Sanofi processes, procedures and appropriate tools in force, in connection with the concerned Global Quality functions. undefined Product-related quality events产品相关的质量事件： Escalate quality events as necessary occurring at the country level according to defined processes and manage subsequent quality alerts and product alerts (as appropriate). undefined Coordinate product recalls as per global and local (where applicable) processes, including mock recalls if applicable. undefined China MAH/MAHD Post-market Quality Obligation Implementation中国药品上市许可持有人上市后质量管理及境内责任人质量管理义务： Establish, maintain and implement related quality process for China MAH/MAHD regulation compliance, including but not limited to: undefined Annual product report according to China DAL, VAL & MAH related regulations. undefined Quality communication with varied manufacturing sites and global quality for product quality. undefined Product traceability management. undefined Interaction with China health authority. undefined Validation验证： Manage the validation that may impact GSP/GDP process or operations by leading multidisciplinary exchanges and actions plans when necessary. undefined GMP and GDP Activities, where applicable GMP和GDP活动（需要时）： Perform supplier & customer certification. undefined Ensure distributor’s license and relevant information can meet GSP requirements. undefined Ensure quality oversight of distributors (buy and sell products