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

Main Accountabilities

主要职责

Ø  Compliance

·       Developing, implementing, and maintaining an effective compliance program

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

·       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

·       Provide training and guidance to employees on compliance topics from global Sanofi standards applicable for the site

·       Coordinating and managing regulatory inspections and audits from external bodies

·       Identifying compliance risks and contributing to the development of strategies to mitigate them

·       Collaborating with other departments, such as legal and P&C, to manage compliance issues

·       Ensuring any compliance incidents are properly reported and investigated with the implementation of appropriate corrective actions

·       Overseeing the maintenance and management of compliance-related documentation

·       Identifying and leading continuous improvement initiatives to enhance the compliance with appropriate health regulations

·       Is or host the Business Owners for Risk management, quality alerts

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

·       开发、执行并维护一套有效的合规管理体系

·       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

·       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

·       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

·       为员工提供培训和指导，涉及适用于本站点的赛诺菲全球标准中的合规主题

·       协调和管理来自外部机构的法规检查和审计

·       识别合规风险，并协助制定缓解策略

·       与其他部门协作,如法务和人力资源部门,共同管理合规问题

·       确保合规事件得到妥善报告和调查,并实施适当的纠正措施

·       监督合规相关文件的维护和管理

·       识别并领导持续改进举措,以加强对相关健康法规的合规性

·       担任或主持风险管理、质量警报的业务负责人

·       领导和管理合规团队,包括招聘、培训、辅导、职业发展和绩效评估

Ø  Quality Risk Management

·       Ensuring the appropriate global harmonized methodology (incl. tool) is followed to assess and document quality risks

·       Reviewing periodically the ongoing quality risks with risk owner and risk leader to reassess their control level in collaboration with Site Risk Officer

·        Maintaining a living risk library and ensuring periodic review process is done

·       Monitoring and reviewing risks metrics to ensure continuous improvement in quality risk management process

·       Collaborating with other groups and functions for the appropriate use and implementation of the Quality risk management methodology (e.g., deviation, complaints)

·       Providing support during regulatory inspections and audits by presenting the necessary documentation and responses

·       Representing the site in the quality risk management (QRM) CoP led by global and ensuring local communication. If requested, participating in the CoE. 

·       Developing and delivering training programs principles and practices.

·       Ensuring that all risk assessments are conducted with trained facilitators

·       确保遵循适当的全球统一方法（包括工具）来评估和记录质量风险

·       与风险负责人和风险领导者定期审查持续的质量风险，与现场风险官员合作重新评估其控制水平

·       维护动态风险库并确保定期审查流程的执行

·       监控和审查风险指标，以确保质量风险管理流程的持续改进

·       与其他小组和职能部门合作，适当使用和实施质量风险管理方法（例如，偏差、投诉）

·       在监管检查和审计期间提供支持，提供必要的文档和回应

·       代表现场参与由全球主导的质量风险管理（QRM）实践社区，并确保本地沟通。如有要求，参与卓越中心。

·       制定和提供培训项目的原则和实践

·       确保所有风险评估都由经过培训的引导员进行

Ø  Business owner

·       Being the Business Owner of a given quality process for the site. Owning process, system, and data

·       Conducting regular routine data quality checks and validations to identify and address any process, system, or data issue

·       Developing and delivering training programs principles and practices

·       Identifying and assessing risks related to the process in scope and implementing mitigation strategies

·       Leading continuous improvement initiatives on site, in line with global processes and practices

·       Overseeing the computerized systems associated with the process to ensure they meet all requirements

·       Establishing and monitoring key performance indicators in line with global guidance

·       Representing the site in the CoP led by global and, if requested, participating in the CoE and ensuring local communication 

·       Representing Sanofi global quality when interacting with health authorities for global processes

·       担任现场特定质量流程的业务负责人，负责流程、系统和数据的管理

·       定期进行常规数据质量检查和验证，以识别和解决任何流程、系统或数据问题

·       制定和提供培训项目的原则和实践

·       识别和评估与范围内流程相关的风险，并实施缓解策略

·       在现场主导持续改进举措，与全球流程和实践保持一致

·       监督与流程相关的计算机化系统，确保其满足所有要求

·       根据全球指导方针建立和监控关键绩效指标

·       代表现场参与由全球主导的实践社区，如有要求，参与卓越中心并确保本地沟通

·       在与卫生当局就全球流程进行互动时，代表赛诺菲全球质量部门

Section 3: Key Involvement in Decision-Making Process

第三部分：在关键决策过程中的参与

Key Roles (D,A,I)

关键角色（D/A/I）

Ø  Compliance Manager

·       Support management on compliance topics (A)

·       Review the relevance of remediation action from findings from internal and external audits related to health-related topics (D)

·       Advise on improvements to compliance processes and systems (A)

·       Decide on risk mitigation strategies (D)

·       Decide on corrective actions for compliance incidents (D)

·       Advise on continuous improvement initiatives (A)

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

·       在合规主题上为管理层提供支持 (A)

·       审查整改措施的相关性，针对与健康相关主题的内部和外部审计发现 (D)

·       就合规流程和系统的改进提供建议 (A)

·       决定风险缓解策略 (D)

·       决定合规事件的纠正措施 (D)

·       就持续改进举措提供建议 (A)

·       与全球团队协调质量警报和批次召回流程 (A)

Ø  Quality Risk Management

·       Decide on eligibility of quality risk for entry in the risk profile (D)

·       Develop and maintain risk matrix/heat map and support management on Quality risk topics (A)

·       Advise on quality risk management strategies and improvements (A)

·       决定质量风险是否符合纳入风险档案的资格（D）

·       制定和维护风险矩阵/热力图，并在质量风险主题上为管理层提供支持（A）

·       就质量风险管理策略和改进提供建议（A）

Ø  Business owner of Recall and QEE

·        Establish and prioritize process evolutions for the site (D)

·       Support audit and inspection and present the process to auditors and inspectors (A)

·       Proactively identify remediation actions from findings from internal and external audits (A), under control of the global process owner

·       Identify training needs (A)

·       Is informed of inspections and audits outcome (I)

·       为现场建立流程演进并确定优先级（D）

·       支持审计和检查，并向审计员和检查员介绍流程（A）

·       在全球流程负责人的控制下，主动识别来自内部和外部审计发现的补救措施（A）

·       识别培训需求（A）

·       被告知检查和审计结果（I）

Pursue Progress. Discovery Extraordinary.

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