Job title职位名称: Manager, Quality Assurance operation APU 质量保证运营APU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 Assurance operation APU 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。

• Batch review and preparing batch disposition for all intermediates and finished goods manufactured in his/her area. (final accountability is under the QP or equivalent)

负责批次审查并准备所在区域内生产的所有中间产品和成品批次处置的信息（最终责任由QP或等同人员承担）。

• Develop and implement the annual quality assurance operation objectives in alignment with the organizational strategy, vision, and objectives

根据工厂的战略、愿景和目标制定并实施年度质量保证运营目标。

• Implement quality operation procedures supporting the manufacturing activities

实施用于支持生产活动的质量操作流程。

• Ensure the timely closure of quality events such as deviations, CAPAs, and change controls to maintain compliance and operational efficiency

确保及时关闭偏差、CAPA和变更等质量事件以保持合规和运营的效率。

• Overseeing the entire manufacturing process to ensure that all steps are validated and adhere to Standard Operating Procedures (SOPs)

监督整个生产过程，确保所有步骤都经过验证并遵循标准操作流程（SOP）。

• Monitor key performance indicators (KPIs) and metrics for the quality assurance operation, and report on the performance and effectiveness.

监控质量保证运营的关键绩效（KPI）和指标，并汇报绩效和有效性。

• Promote a culture of quality and continuous improvement. Identify and drive continuous improvement initiatives and projects to enhance the quality assurance operation efficiency and effectiveness.

促进质量和持续改进文化。确定并推动持续改进计划和项目以提高质量保证运营的效率和有效性。

• Lead and manage the quality assurance operation team, including hiring, training, coaching, professional development and performance evaluation

领导和管理质量保证运营团队，包括招聘、培训、指导、职业发展和绩效评估。

• 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。

• Review and prepare manufacturing documentation for Batch disposition by QP (A)

审查并准备生产记录文档以供QP进行批处理裁决。

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

制定计划用以改进质量保证运营的操作流程和体系。

• Identify and escalate possible quality alert risks (A)

识别并上报可能的质量警报风险。

• Provide support to quality control processes and improvements (A)

为质量控制流程和改进提供支持。

• Follow progress on quality improvement projects and initiatives (I)

跟踪质量改进项目和计划的进展情况。

• Proactively implement remediation action from findings from internal and external audits related to quality assurance operation (I)

根据与质量保证运营相关的内外部审计结果主动实施纠正计划。

• Developing and implementing comprehensive sterility assurance and microbiological control programs in alignment with the organizational strategy, vision, and objectives

制定并实施与工厂战略、愿景和目标一致的全面无菌保障和微生物控制计划。

• Developing and implementing effective strategies and procedures for sterility assurance and microbiological control across the organization.

制定并实施有效的策略和程序以确保整个工厂的无菌保障和微生物控制。

• Ensuring the compliance of products and processes with applicable sterility assurance and microbiological control regulatory requirements and company quality standards

确保产品和流程符合适用的无菌保障和微生物控制监管要求以及该公司的质量标准。

• Overseeing the validation, qualification and monitoring of methods, equipment and the environment ensuring sterility assurance control

监督方法、设备和环境的验证、确认和监控，确保无菌保证控制。

• Promoting a culture of quality and sterility management and microbiological control across the organization

在全工厂推广质量和无菌管理及微生物控制的文化。

• Define the most appropriate methods and technologies for each product and process (D) to ensure contamination control or sterility

为每种产品和流程定义最合适的方法和技术以确保污染控制和无菌。

• Provide technical expertise and support to other departments and functions on matters related to sterility assurance and microbiological control (A)

就无菌保证和微生物控制相关事宜向其他部门提供技术专业知识和支持。

• Lead most critical SA & microbiological events and define the corrective and preventive actions to be taken in response to any non-conformities or deviations related to sterility assurance and microbiological control (A)

领导关键的无菌保障和微生物事件，定义针对于无菌保障和微生物控制相关的任何不合格或者偏差而采取的纠正预防措施。

• Ensure with the team a regular presence (25% of time) on the shopfloor with operational teams to carry out oversight, coach and develop knowledge (A)

确保团队定期（25%的时间）与质量保证运营团队一起前往车间，进行监督、指导和发展知识。

• Provide trainings programs and strategies for SA competencies development & operator's qualification/requalification for SA systems (D)

为无菌保证能力发展和操作员的无菌资格确认和再确认提供培训计划和策略。

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: At least 10 years of experience in quality assurance, preferably in a leadership or managerial role.

工作经验:至少10年质量保证经验，具有领导管理岗位经验者更优。

• 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: Extensive knowledge of quality assurance principles, standards, methodologies, and tools

专业技能:深入了解质量保证原则、标准、方法和工具。

• 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.

Pursue Progress. 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!

Pursue progress, discover extraordinary

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, ability or gender identity.

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