M&S-Head of Quality System & Compliance-Beijing

Job title职位名称: Head of Quality System and compliance 质量体系与合规经理

• Location工作地点： Beijing北京

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 Head 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：

·Developing, implementing, and maintaining an effective compliance program

·Ensuring that the site complies with all laws, regulations, and standards applicable in the pharmaceutical industry

·Establishing and maintaining effective relationships with regulators, industry associations, customers, suppliers, and other stakeholders, and representing the company in compliance-related matters

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

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

·Ensuring that any compliance issues are reported to the relevant authorities in a timely manner

·Managing and resolving any compliance issues or allegations that arise, and taking appropriate corrective and preventive actions

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

·Is or host the Business Owners for risk management, self inspection, quality alerts

·Identifying and driving continuous improvement initiatives and projects to enhance the site compliance, fostering a culture of compliance

·Leading and managing the compliance team, including hiring, training, coaching, professional development, and performance evaluation

·Developing and implementing the annual QMS objectives in alignment with the organizational strategy, vision, and objectives

·Ensuring the Quality Management System is at all times compliant with applicable regulatory requirements and company quality standards

·Maintaining a system to ensure quality systems are properly identified, tracked, and mitigated. This includes all quality processes and third party management

·Ensuring documentation system is in place and updated on a regular basis

·Ensuring the high quality and 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

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

·Providing QMS guidance, support, and training to all staff and stakeholders, and promoting a culture of quality and compliance across the organization

·Establishing metrics and monitoring data for the QMS activities to identify trends and issues and to implement action plan

·Establishing and monitoring key performance indicators (KPIs) and metrics for the QMS, and reporting on the QMS performance and effectiveness

·Promoting a culture of quality throughout the QMS organization

·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

·Evaluating and recommending new technologies, tools, and methods to enhanceprocesses and outcomes

·Leading management reviews to assess the effectiveness of the QMS and leading the coordination of all elements of the site management reviews

·Leading and managing the QMS team, including hiring, training, coaching, and performance evaluation

·制定、实施和维护有效的合规计划

·开发、执行并维护一套有效的合规管理体系

·• 确保现场符合制药行业适用的所有法律、法规和标准

·保证现场运营符合制药行业相关的所有法律法规及标准要求

·• 与监管机构、行业协会、客户、供应商及其他利益相关方建立并维护有效关系，并在合规相关事务中代表公司

·建立并保持与监管部门、行业组织、客户、供应商和其他相关方的良好关系，在合规事宜中作为公司代表

·• 维护系统以确保合规和质量风险得到妥善识别、跟踪和缓解

·建立并维护体系，确保合规及质量风险被正确识别、追踪和控制

·• 确保公司始终为监管机构关于档案合规性相关主题的检查做好准备

·保证公司随时准备好应对监管部门针对档案合规性等相关主题的检查

·• 确保任何合规问题及时向相关主管部门报告

·保证所有合规问题能够及时向相关监管机构汇报

·• 管理和解决出现的任何合规问题或指控，并采取适当的纠正和预防措施

·处理并解决任何合规问题或投诉，实施相应的纠正及预防行动

·• 建立和监控现场合规的关键绩效指标(KPIs)和指标，并向管理层报告结果

·制定并监测现场合规的关键绩效指标及衡量标准，定期向管理层汇报成果

·• 担任或承接风险管理、自检、质量警报的业务负责人

·作为或承担风险管理、自我检查、质量警报等业务的负责人角色

·• 识别和推动持续改进举措和项目以增强现场合规性，培育合规文化

·发现并驱动持续改进计划和项目来提升现场合规水平，营造合规文化氛围

·• 领导和管理合规团队，包括招聘、培训、辅导、专业发展和绩效评估

·领导并管理合规团队，涵盖人员招募、培训指导、职业发展及绩效考核

·• 制定和实施与组织战略、愿景和目标一致的年度QMS目标

·开发并执行与组织战略、愿景及目标相协调的年度质量管理体系目标

·• 确保质量管理体系始终符合适用的法规要求和公司质量标准

·保证质量管理体系始终满足相关法规要求及公司质量标准

·• 维护系统以确保质量体系得到妥善识别、跟踪和缓解。这包括所有质量流程和第三方管理

·建立并维护体系，确保质量系统被正确识别、追踪和管控，涵盖所有质量流程及第三方管理

·• 确保文档系统到位并定期更新

·保证文档体系建立完善并定期更新维护

·• 确保质量事件（如偏差、CAPA和变更控制）的高质量和及时关闭，以保持合规性和运营效率，同时控制质量积压

·保证质量事件（偏差、纠正预防措施、变更控制等）得到高质量且及时的关闭处理，维持合规性和运营效率，同时控制质量工作积压

·• 确保运营许可培训计划到位，以保证所有员工具备其岗位所需的知识和资质

·保证运营资质培训项目落实到位，确保所有员工拥有履行职责所需的知识和资格

·• 为所有员工和利益相关方提供QMS指导、支持和培训，并在整个组织中推广质量和合规文化

·向全体员工及相关方提供质量管理体系的指导、支持和培训，在全组织范围内推进质量与合规文化

·• 建立QMS活动的指标和监控数据，以识别趋势和问题并实施行动计划

·制定质量管理体系活动的衡量指标并监控数据，识别趋势与问题，制定并实施行动方案

·• 建立和监控QMS的关键绩效指标(KPIs)和指标，并报告QMS的绩效和有效性

·制定并监测质量管理体系的关键绩效指标及衡量标准，汇报QMS的绩效表现和有效性

·• 在整个QMS组织中推广质量文化

·在质量管理体系组织内全面推进质量文化建设

·• 识别和推动持续改进举措和项目以提升QMS的效率和有效性，利用新技术、工具和方法作为关键手段，培育持续改进文化

·发现并驱动持续改进计划和项目来增强质量管理体系的效率与效果，运用新技术、新工具和新方法作为核心手段，营造持续改进文化

·• 评估和推荐新技术、工具和方法以增强流程和成果

·评价并建议采用新技术、新工具和新方法来改善流程和提升成果

·• 领导管理评审以评估QMS的有效性，并领导协调现场管理评审的所有要素

·主导管理评审工作以评估质量管理体系的有效性，统筹协调现场管理评审的各项要素

·• 领导和管理QMS团队，包括招聘、培训、辅导和绩效评估

·领导并管理质量管理体系团队，涵盖人员招聘、培训指导及绩效考核

About you 任职资格:

• 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
• 通用技能: 良好的沟通与合作能力。
• 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。
• Take the Lead: Aim Higher, Act for Patients, Be Bold, Lead Together

敢为人先: 志存高远，心系患者，敢于创新，聚力同行

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!