M&S-Head of Quality Assurance Operation Unit (APU) & Sterility-Beijing

Job title职位名称:

Head of Quality Assurance operation unit (APU) & Sterility 高级质量保证经理

• Location工作地点： Beijing

About the job工作职责

Our Team我们的团队：

Manufacturing & Supply consists of 3 manufacturing platforms based on global business units, as well as supporting functions of Quality, Market Supply and Strategy. We are committed to making best class medicines with excellent strategies and tools and delivering them to our patients.

制造与供应事业部包含以3个全球事业部为基础的制造平台，以及质量、供应商、精益战略等支持部门。致力于用优异的战略和工具制造优质的药品并传递到患者手中。

Main responsibilities职责描述：

• Assist site quality head to ensure that product is manufactured and controlled under cGMP condition and marketing authorization, develop quality system to be in alignment with local cGMP, industry standards, regulatory expectations and Sanofi requirements

协助工厂质量负责人保证药品生产和质量控制符合GMP以及销售市场国家的要求，完善质量管理体系保证符合国内、国际和赛诺菲的要求

• Keep on developing the quality system and establish or update the related SOP according to the global quality standard / cGMP and other local requirements together with other departments.
• cGMP以及地方法规要求建立或更新质量保证体系，配合其他部门对标准操作规程进行不断改进升级和完善

• Ensure the cGMP compliance of the calibration, utilities, systems, production processes (raw materials, in process product, finished products) and control procedures
• GMP符合性
• Make decision of batches, materials and quality event in compliance with the registered specifications and cGMP requirements
• GMP要求
• Review the batch manufacturing / packing master records and review the annual products quality
• /批包装记录，回顾年度产品质量情况
• As the Lead of operation QA to respond to operational business. Establish procedures and ensure continuous improvement of the PCU quality oversight and GMP documentation. Provide quality assurance oversight by performing routine walk-throughs and inspections on production, laboratory, warehouse, engineering deportment and other areas assigned where the business is responsible to ensure that all aspects of operations comply with cGMP legal and regulatory requirements as well as global guidelines
• 建立流程并持续改进关于PCU质量运营监督的设计和GMP相关的支持文件。通过日常现场巡视及检查的方式对生产，实验室，库房，工程以及其它区域进行监督，保证所有相关操作符合cGMP、注册法规以及总部文件要求
• Ensure the plan in place. ensures all critical process parameters and quality attributes are monitored or analyzed.
• Manage procedures to correct deviations and out of specification （OOS） results and monitor the corrective and preventive actions (CAPA) to prevent the repetition of the not compliance instance. providing support and advice during cross functional investigations and when required, sampling procedures and directions for recording and reporting quality data. As quality representative, approve deviation and lab investigation, to ensure the process handling meet the requirement of regulatory and Sanofi procedure.
• OOS 程序并监控CAPA的落实以预防不符合事件的重现。如需要，在跨部门调查中提供支持和建议如提出取样方案，调查方向以及汇报相关质量数据。作为质量代表批准偏差及实验室调查，确保整个过程符合法规及总部要求。
• Support CAPA implementation and review CAPA effectiveness. As quality representative, approve the extension requests of CAPA in systems.
• CAPA执行和回顾CAPA效果。作为质量代表批准系统中CAPA的延期请求。

• Evaluate the change control related sterile and non-sterile manufacture and follow the execution. Act as the final evaluator of change quality and sterile assurance to ensure changes are properly evaluated
• 作为变更质量及无菌保障最终评估人评估确保变更得到正确的评估。

• Support and participate project or improvement of products and product launch and technical study. Ensure a proper prioritization approach for high-level product assessments, product validation, compliance activities
• Evaluate suppliers relative to sterile operation, to assure they can supply product that meets established requirements.
• Participate self-audit, global audit and regulatory inspection to improve the site GMP compliance
• GQA审计和法规检查，不断改进工厂的GMP符合性
• Establish and assure a continuous GMP training to maintain an high level of GMP awareness in all the staff 
• GMP培训以维护全体员工高水准的GMP意识
• Lead the complaints investigation related to sterile and non-sterile products in Beijing Site.

• Ensures quality risks are properly managed (identification, assessment, control, communication). 
• Play a key role as site microbiology contamination control expert to ensure the manufacturing system and quality control system fulfil the regulatory, quality and technical requirements.
• Establish a robust contamination control strategy and sterility assurance system. Provide technical proposal on clean zone re-construction, optimization process, utility control , and environmental monitoring from sterility assurance perspective.
• 从无菌保障方面提供专业技术意见，包括针对洁净区改造，无菌工艺优化，公用工程监控，环境监控等。
• Trouble shooting for sterility issues in Process, Equipment, Utility, testing, material, etc.
• Deploy technical training in site level and implement the CCS regarding the sterility assurance.
• Manage sterility assurance related projects.
• Participant the establishment of recall process and recall activity.
• Manages the QA team under his/her responsibility with respect to all applicable rules. Perform people performance management. Make individual develop plan with personnel within QA team and build up technical ladder. Training curriculum up to date and ensure QA team trained according to the training curriculum.
• QA团队。 进行人员绩效管理。制定团队的个人发展计划，建立人才梯队。确保团队人员按计划要求实施培训，并保证培训计划及时更新。
• Ensure oversight and perform activities related with Medical Device according to the current Good Supply Practice (GSP) regulations.
• GSP）执行医疗器械相关活动。
• Ensure CMO quality system management when Beijing site as MAH,
• MAH时，确保CMO质量系统管理符合相关监管要求。
• Execute any other tasks assigned from site quality head.

• HSE responsibilities

HSE 职责

• 负责贯彻公司HSE的有关规定，把公司HSE制度的措施贯彻到每个具体环节。
• 对团队的HSE负直接领导责任，将HSE工作纳入工作计划中。
• 定期开展本团队HSE隐患排查治理工作，制定整改计划并按时完成隐患整改。
• 组织实施本团队HSE管理目标计划，落实HSE规章制度、HSE操作规程和HSE技术措施计划，把职业卫生工作列入议事日程。
• 负责团队HSE教育与考核工作；及时处理员工提出的意见。
• 积极配合HSE管理工作，防止各类事故的发生。
• 按集团规定参加月度MSV，形成有效记录。参加每天+QDCI会议，监督本团队+QDCI是否有效开展。
• 发生安全、环保和职业健康事故时，迅速上报，并及时组织抢救。
• 参加事故调查分析工作，从质量管理角度分析事故原因，提出事故防范措施。

• Emerge responsibilities

• Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy : "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.
  • “以药品质量为第一要务，通过技术手段，行为规范，人为意识，不断降低产品价值中的能耗比重，造福广大用户，促进企业发展”要求每位员工具有良好的节能意识，积极的节能行动，协助能源管理体系的持续开展
• Support the initiation, approval and implementation of energy-saving projects
• 支持节能项目的发起，批准，实施
• According the energy-saving plan, promote the implementation of energy-saving projects
• 根据节能方案，推进节能项目实施

About you 任职资格:

List here ideally the must-haves criteria to be successful on the role.

请列出胜任该职位所必须具备的条件。

• Experience: 5+ years' experience in quality control and /or quality assurance, 3 years management position, 3 years of experience in sterility assurance and microbiological control in the medical device, pharmaceutical, biotechnology, or> related industry.

工作经验: 至少5年QA或QC工作经验，3年以上管理经验，3年以上无菌药品生产及质量相关经验

• Soft skill: Good communication, Able to burden pressure, Think strategically, Make decisions, Good leadership

通用技能: 良好的沟通能力，能够耐受压力，战略思维，果敢决策，领导能力

• Technical skill: Must be a committed “quality” professional with knowledge of regulated quality systems within the pharmaceutical or related industry. Knowledge of analytical chemistry and microbiology.

专业技能: 必须具备制药或相关行业的质量体系的“质量”专业知识经验。具备分析化学和微生物知识。

• Education: At least a bachelor degree in pharmacy or chemistry or biology disciplines

教育背景: 至少药学或化学或生物技术或生物学或相关专业大学本科以上学历

• Languages: Good English verbal & written communications.

语言要求: 英语口语和书写熟练

• Play to Win Behaviors: Stretch; Take Action; Act for Patients & Customers; Think One Sanofi

全力致胜行为: 超越自我, 主动出击, 以患者和客户为本, 团结一致

Pursue progress, discover extraordinary进无止境，探索菲凡

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

进步，外部可见。更好的药物，更好的效果，更高的科学。但是进步离不开人去创造——来自不同背景、不同地区、担任不同岗位的人。所有人都团结在“创造奇迹的渴望”这一使命下。让我们成为这样的人。

在赛诺菲，不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同，我们为所有人提供平等的机会。

观看我们的 ALL IN 视频，并在 sanofi.com 网站上查看我们有关多元化、公平性、包容性的举措。