Manufacturing and Supply
Wo Wunder
der Wissenschaft
für Patient*innen
Realität werden

Job title职位名称: Head of Quality/质量总监，质量受权人

• Location工作地点： Beijing 北京

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：

Please indicate here the main job responsibilities请列举该职位的主要工作职责。

Final decision on acceptance for use or rejection of all raw materials, active pharmaceutical ingredients, package components, printed packaging materials, in process products and drug products.
Review and approval of standard operating procedures for conformance to the CGMPS and their integration into a quality system designed to prevent and correct quality problems. GMP要求，并整合设计到质量系统中以预防和改进质量问题。 Review and approval of master production documentation to assure adherence to registration, company standards, GMP and validation. GMP和验证等的要求。 Maintenance and management of testing facilities to assure that raw materials, active ingredients, packaging materials, in process materials and drug Product meet their specifications, including all test methods and material specifications.
Ensure a quarantine system to guarantee that incoming materials are not used before approval and finished drug products are distributed only after release.
Final review of manufacturing and quality control documents (batch manufacturing records, batch packaging records, certificate of analysis) prior to the release of a batch of product.
Ensure that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirements of the Marketing Authorization.
Meet the QP qualification requirements laid down in the national legislation; continuously at the disposal of the holder of the Manufacturing Authorization to carry out their responsibilities.
Ensure approval and monitoring of suppliers of materials, contract manufacturers and providers of other GMP related outsourced activities. GMP相关的外包活动的批准和监控。 Ensure a timely and effective communication and escalation process exist to raise quality issues to the appropriate levels of management.
Review and approve all the validation protocols (equipment, system and processes etc) as well as the validation reports.
Review and approve the product quality reviews for marketed products.
Ensure the organization of internal audits to assure conformance to CGMPS and related regulatory requirements as well as audits to contractors/suppliers to assure they can supply product that meets established requirements. GMP及相关法规要求，开展审计以保证合同方、供应商能提供符合要求的产品。 Manage procedures to correct deviations and out of specification results and monitor the corrective and preventive actions (CAPA) to prevent the repetition of the not compliance instance. Establish and manage a change control system. OOS程序并监控整改和预防性整改措施的落实以预防不符合事件的重现。建立并管理改变控制系统。 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。 Assure the correct handling of product recall and customer complaints.
Control of  returned  non-defective  products  before  reintroduction  and distribution into the market when applicable。
Establish a stability program for the distributed products.
Organize and maintain the retention of retained samples as well as all production, validation and GMP related documents. GMP相关文件。  Ensures quality risks are properly managed (identification, assessment, control, communication). 
Manages the quality teams under his/her responsibility with respect to all applicable rules.
Responsible for Beijing DC, detail see quality agreement ID285259/QA014. ID285259/QA014. Quality head HSE responsibility: HSE职责： Responsible for following the company’s HSE policy, and integrated all requires into daily job. HSE的有关规定，把公司HSE制度的措施贯彻到每个具体环节。 Incorporate HSE work into the work planHSE工作纳入工作计划中。Organize the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan.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。Regularly carry out to identify HSE potential hazards and develop action plan and finish on time.HSE隐患排查治理工作，制定整改计划并按时完成隐患整改。Timely working out of employee opinions.HSE教育与考核工作；及时处理员工提出的意见。Actively cooperate with HSE management to prevent accidents happens.HSE管理工作，防止各类事故的发生。Participate monthly MSV, regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement remediation. MSV, 定期开展本部门各级+QDCI会议，结合HSE8要求，及时、正确填写和反馈各类HSE问题，并积极落实整改。Participate in the investigation for accidents, analyze the root causes of accidents from the quality management perspective, and related CAPA.
Member of HSE management committee and crisis management team,responsible for design annual department PASS plan, and ensure implementation as planned. HSE管委会和危机管理小组的成员, 负责制定年度部门PASS计划，并按进度组织实施。

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: Minimum 10 years experiences in quality control and /or quality assurance, 5 years of which in management position.

工作经验:至少10年QC或QA工作经验，5年以上管理经验。

• 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 regulation quality systems within the pharmaceutical or related industry.

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。

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

教育背景: 至少药学或化学或生物学或相关专业大学本科学历

• Languages: Good English verbal & written communications.

语言要求: 熟练的英语口语和书写能力

• 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

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

PursueProgress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, 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!

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Pursue Progress. Discovery Extraordinary.

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