M&S-Senior Manager of Quality System and Compliance-Shenzhen

Job title职位名称: Manager , Quality System and compliance 质量体系和合规经理

• Location工作地点： Shenzhen 深圳

About the job工作职责

meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Manager, Quality System and compliance within our M&S China-Shenzhen Site, will be to making best class medicines with excellent strategies and tools and delivering them to our patients.

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：

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

• Ensuring the Quality Management System is all-time compliant with applicable regulatory requirements and company quality standards. 

确保质量管理体系始终符合适用的监管要求和集团总部要求。

• Ensuring the timely closure of quality events such as deviations, CAPAs, and change controls to maintain compliance and operational efficiency while also keeping quality backlogs under control.

确保偏差、CAPA和变更等质量事件的及时关闭，以保持合规和运营的效率，同时控制相关工作内容的积压。

• Ensuring license to operate training programs are in place to guarantee that all employees have the knowledge and qualifications needed for their tasks

确保符合经营许可的培训计划，以保证所有员工具有完成自身任务所需的知识和资格。

• Providing QMS guidance, support, and training to all staff and stakeholders, and promote a culture of quality and compliance across the organization.

为所有员工和相关方提供QMS指导、支持和培训，在全工厂内促进质量和合规文化。

• Identifying and driving continuous improvement initiatives and projects to enhance the QMS efficiency and effectiveness, leveraging new technologies, tools, and methods as key means and fostering a culture of continuous improvement.

确定并推动持续改进计划和项目，以提高QMS的效率和有效性，利用新技术、工具和方法作为主要手段，培养持续改进的文化。

• Leading and managing the QMS and compliance team, including hiring, training, coaching, and performance evaluation.

领导和管理QMS和合规团队，包括招聘、培训、指导和绩效评估。

• Other Duties: Perform additional responsibilities as assigned by Site Quality Head.

其他职责：履行质量负责人交办的其他职责。

• Define initiatives to maintain and improve quality processes and systems (D).

制定计划以维护和改进质量流程和体系。

• Support senior management on regulatory strategies and compliance issues (A).

支持工厂管理层制定监管策略和合规问题。

• Proactively implement remediation action from findings from internal and external audits related to regulatory issues (I)

主动实施在内外部审计中缺陷项的纠正措施。

• Developing, implementing, and maintaining an effective compliance program

制定、实施和维护有效的合规计划。

• Ensuring that the company complies with all laws, regulations, and standards applicable in the pharmaceutical industry, and simultaneously establishing and maintaining effective relationships with regulators, industry associations, customers, suppliers, and other stakeholders, and representing the company in compliance-related matters.

确保公司遵守制药行业所适用的所有法律法规和标准，同时和监管机构、行业协会、客户、供应商和其他利益相关方建立并保持有效的关系，代表公司处理相关合规业务。

• Maintaining a system to ensure compliance and quality risks are properly identified, tracked and mitigated

维护系统以确保合规性和质量风险得到正确的识别、跟踪和缓解。

• Ensuring the company is always prepared for inspections by regulatory bodies for topics related to dossier compliance

确保公司始终做好迎接监管结构有关注册及资质检查的准备。

• Establishing and monitoring key performance indicators (KPIs) and metrics for the site compliance, and reporting on the results to management.

建立和监控工厂合规性的关键绩效指标（KPI）和衡量标准，冰箱管理层汇报结果。

• Define initiatives to improve the compliance of our processes and systems (D).

制定计划以提高我们流程和系统的合规性。

• Support senior management on compliance topics (A).

在合规性相关的问题上向管理层提供支持。

• define and Execute inspection readiness plan (D)

定义和执行检查准备计划。

• Coordinate quality alert and batch recall process with global team (A)

与总部质量团队协调有关质量警报和批次召回流程。

• Implement and maintain qualification and validation strategies, plans, protocols, and reports, in collaboration with internal and external stakeholders

与内外部相关利益方合作，实施和维护验证策略、计划、方案和报告。

• Maintain and update the validation master planand procedures, and ensure alignment with the company's quality management system 

维护和更新验证主计划和程序，确保和公司的质量管理体系的要求保持一致。

• Ensure the compliance of qualification and validation with applicable regulatory requirements and company quality standards. 

确保验证符合适用的监管要求和公司的质量标准。

• Maintain a system to ensure compliance and quality risks are properly identified, tracked and mitigated

维护验证系统，确保能够正确识别、跟踪和减缓合规性和质量风险。

• Ensure the proper documentation, review, and approval of qualification and validation deliverables, such as risk assessments, traceability matrices, test scripts, deviations, and summary reports

对验证相关活动相关内容进行记录、审阅和批准（例如风险评估、追溯性矩阵、测试记录、偏差和报告）。

• Ensure that all equipment and facilities are properly qualifiedand validated

确保所有的设备和设施都经过适当的确认和验证。

• Oversee the execution of qualification and validation studies

监督确认和验证研究的执行情况。

• Establish metrics and monitor data for the qualification and validation activities, to identify trends and issues and to conduct periodic reviews and re-validation as necessary.

为确认和验证活动建立指标和监控数据，以确定趋势和问题，并根据需要定期进行审阅和再验证。

• Establish and monitor key performance indicators (KPIs) and metrics for the qualification and validation, and report on the qualification and validation performance and effectiveness.

建议和监控验证活动相关的关键绩效指标（KPI）和衡量标准，并报告验证活动的绩效和有效性。

• Promote a culture of quality throughout the qualification and validation organization

在全工厂推广确认和验证相关的质量文化。

• Identify and drive continuous improvement initiatives and projects to enhance the qualification and validation efficiency and effectiveness fostering a culture of continuous improvement

确定并推动持续改进计划和项目，以提高验证活动的效率和有效性，培养持续改进的文化。

• Evaluate and recommend new technologies, tools, and methods to enhance qualification and validation processes and outcomes

评估并推荐新技术、工具和方法，以优化验证的流程和结果。

• Lead management reviews to assess the effectiveness of the qualification and validation activities

领导管理回顾，评估验证活动的有效性。

• Prioritize and allocate qualification and validation projects, resources, and budget (D)

确定验证项目、资源和预算的优先顺序并进行分配。

• Endorse qualification and validation strategies, using a TRT approach (D). Approve the site Validation Master Plan (sVMP) (D)

适用TRT的方法确定验证策略。批准验证主计划。

• Support and coordinate with other departments to ensure smooth validation processes (A)

支持并协调其他部门以确保验证活动的顺利进行。

• Prepare internal and external audits and HA inspections related to qualification and validation by identifying Q&V risks (A) and propose mitigation plan (D)

通过识别验证风险和缓解计划来准备内外部及药监机构的审计活动。

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 of experience in quality management. A minimum of 10 years of experience in compliance, quality, or regulatory affairs in the pharmaceutical industry, preferably in a leadership role.

工作经验: 至少10年质量管理经验。至少10年药品生产行业合规、质量、注册经验及领导岗位。

• Soft skill: Proficient in interpersonal skill, presentation skill, communication skill, leadership abilities, teamwork influence，complex problem-solving skill and etc.,

通用技能: 人际交往能力、沟通技巧、演讲能力、领导力、团队合作影响力和复杂问题解决能力等

• Technical skill: Demonstrated experience in managing one or several quality systems and processes in the past with team management experience. A thorough knowledge and understanding of the pharmaceutical industry and the applicable laws, regulations, and standards. Proven experience in hosting inspections from Health authorities

专业技能:具有管理一个或多个质量体系和流程的丰富经验，并具有团队管理经验。对制药行业及所适用的法律法规和标准具有深刻的了解和理解。具有丰富承接药监结构检查的审计经验。

• Education: A bachelor’s degree in pharmacy, biotechnology, chemistry or related field

教育背景: 药学、生物技术、化学或相关领域的本科学位

• Languages: Proficient in listening, speaking, reading and writing, hold CET6 and above language certificate is preferred 

语言要求: 精通英语听说读写，或持有大学英语六级或以上相关英文证书；

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!