Job title职位名称: Associate manager of Quality system and compliance

• Location工作地点:Beijing

About the job工作职责

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and 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 Associate manager of Quality system and compliance within our M&S China-BEI 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。

• Assists the 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cGMP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。

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

确保工厂质量管理体系符合本地法规及公司的质量标准

• 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.

确保及时关闭偏差'CAPA'变更等质量事件来保证持续的合规和高效的运营同时保证质量积压工作处于可控水平。

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

确保一个运行的培训计划来给予岗位许可以保证所有的员工都能相应的知识技能和资质认证来完成他们工作。

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

向所有的员工和伙伴提供质量管理体系的指导'支持和培训'并且在组织内宣传质量和合规的文化。

• 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举措和项目'以提高质量管理体系的效率和有效性'利用新技术,新工具和新方法作为关键手段'并培养持续改进的文化。

• Drive continuous improvement of quality system. It includes regulatory compliance, gap analysis, coordination for quality audits (internal audit, external audit, self- inspection), technical dossier for registration, change control, quality documentation, archiving management'counterfeit and pharmacovigilance case reporting management' GMP training, product complaints' third party management'validation management system, quality risk management, data integrity etc.

引领质量体系的持续改进'包括法规符合性'差距分析'协调各项质量检查(内部检查'外部检查及自检)'变更管理'质量文件管理'档案室管理'GMP培训管理'产品投诉管理'疑假处理和不良反应上报'供应商管理'验证管理体系' 质量风险管理及数据完整性。

• Lead digital transformation of quality system improvement in site Beijing' maintain digital tools such as QualiPSO and iLearn.

领导北京工厂质量体系的数字化转型'维护QualiPSO及iLearn等数字化管理工具。

Responsibility of quality system management

质量体系职责...

• Develop, implement, and maintain an effective quality management system in compliance with China GMP regulations.

根据中国GMP法规'制定,实施和维护有效的质量管理体系。

• Manage the change control process, including assessing the impact of proposed changes, ensuring appropriate documentation, and coordinating with relevant departments to implement approved changes.

管理变更控制过程'包括评估所提议改变的影响'确保适当的文件记录'协调相关部门实施已批准的改变...

• Coordinate and perform periodic self-inspections to ensure compliance with GMP regulations and company policies.

协调和执行定期的自检活动'确保符合GMP法规和公司政策的要求。

• Manage external audits, including coordinating audit schedules, providing necessary documentation and support, and ensuring timely closure of audit findings.

管理外部审计'包括协调审计日程'提供必要的文件和支持'确保及时关闭审计结果。

• Oversee the management of customer complaints, including case receive, root cause investigation, problem solving and communication with customers to ensure customer satisfaction.

监督客户投诉的管理'包括事件的接收,原因的调查,事件的解决'与客户投诉专员沟通以确保达成客户满意度。

• Ensure proper reporting and management of suspected falsification and adverse reaction incidents according to regulatory requirements.
  按照法规要求'确保对疑似伪造和不良反应事件进行适当的报告和管理。
• Establish and maintain a robust supplier management system, including conducting supplier assessments/audit, monitoring supplier performance, and handle compliant for supplier.
  建立和维护一个健全的供应商管理体系'包括进行供应商评估/审计,监控供应商绩效'处理与供应商相关的投诉事件。
• Ensure the proper control and management of documents, including the development and maintenance of document control procedures and practices. Ensure the compliance of document writing'review and approval' effective and obsolescence management' tracking the effectiveness of current documents and logbooks' update old version documents on time.
  确保良好的文件控制和管理'包括制定和维护文件控制程序和实践。确保相关文件和记录的编写'审核'生效和退役的合规管理'跟踪文件和记录的有效性并进行必要的更新和修订。
• Oversee the management of the archive room, ensuring proper storage and retrieval of records in compliance with regulatory requirements.
  监督档案室的管理'确保符合法规要求'记录的正确存储和检索。
• Manage quality department Key Performance Indicators (KPIs), including establishing relevant metrics, monitoring performance, and implementing corrective actions as needed.
  管理质量部门的关键绩效指标(KPI)'包括建立相关指标'监测绩效'并根据需要实施纠正措施。
• Develop and implement training programs to ensure employees are adequately trained on GMP regulations, company policies, and quality system requirements. Manage and maintain local training data in iLearn system to provide training service for Beijing site.
  制定并实施培训计划'确保员工在GMP法规,公司政策和质量体系要求方面得到适当的培训。管理和维护iLearn 系统的运行'维护系统上的本地数据以实现为北京工厂提供培训服务。
• Oversee the management of customer complaints, including case receive, root cause investigation, problem solving and communication with customers to ensure customer satisfaction.

监督客户投诉的管理'包括事件的接收,原因的调查,事件的解决'与客户投诉专员沟通以确保达成客户满意度。

• Maintain overview of state of validation at site and establish the project prioritization across site. Establish and maintain validation master plan against the business needs and priorities, through the team of validation experts, supervise the execution of the validation completion. Establish and monitor validation KPIs

维护工厂验证的整体状态并制定优先级别'与验证团队合作按时完成和维护验证主计划, 并按照业务需求'协调和监管验证活动的执行完成情况。设定和监控验证关键绩效指标。

• Maintain overview of state of validation at site and establish the project prioritization across site. Establish and maintain validation master plan against the business needs and priorities, through the team of validation experts, supervise the execution of the validation completion. Establish and monitor validation KPIs

维护工厂验证的整体状态并制定优先级别'与验证团队合作按时完成和维护验证主计划, 并按照业务需求'协调和监管验证活动的执行完成情况。设定和监控验证关键绩效指标。

• Lead and support continuous improvement for the quality risk management system, site quality culture, identifying areas for improvement, establishing improvement goals, and implementing and measuring the effectiveness of improvement initiatives.

带领和支持质量风险管理和工厂质量文化的持续改进项目'识别改进领域'确立改进目标'并实施和衡量改进举措的有效性。

General responsibility of team management

其他管理职责

• Perform people performance management. make individual develop plan with personnel within team and build up technical ladder

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。

• Responsible for team budget following the site strategic policy and control the implementation

负责本团队的预算'按照人事和财务政策的要求实施预算和管控。

• Any other specific responsibility appointed by the senior management

其他未尽职责'遵照上一级管理团队的要求执行

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 a bachelor degree in pharmacy or chemistry or biology disciplines with minimum 5 years management experience in production and /or quality assurance.

工作经验: 至少药学或化学或生物学或相关专业大学本科学历'至少5年生产或质量保证工作管理经验。

• Soft skill: Good communication and collaboration, strong leadership

通用技能: 良好的沟通与合作能力'非凡的领导力。

• Technical skill: Must be a committed "quality" professional with knowledge of regualed 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 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: Fluent English in verbal & written.

语言要求: 熟练的英语书写及沟通能力。

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!