Regulatory Compliance Manager

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Maintain a robust Compliance Program for DPS Suzhou site to ensure compliance to local national and international regulatory standards company policies and procedures J&J corporate requirements. 维护DPS 苏州工厂的法规体系以确保符合当地国家和国际的监管标准工厂的政策和流程和强生公司要求

Ensure effective and timely execution of the Internal Audits schedule including deployment of qualified personnel (including knowledge experience and independence) to conduct the

internal audits. 确保有效及时的执行内部审核计划包括合格人员的部署包括知识经验和独立性以进行内部审核

Conduct internal audits of the manufacturing sites according to approved Internal Audit Schedule.根据批准的内部审核计划对生产场所进行内部审核

Establish and maintain regulatory inspection readiness plan at DPS Suzhou site in preparation for any regulatory inspection (internal corporate or external audits). Support manufacturing site regulatory inspections as required. 建立和维护DPS苏州工厂的监管检查准备计划为任何监管检查公司内部或外部审核做准备按要求支持生产场所的合规检查

Review and assess proposed new / revised regulations and incorporate them into the DPS Suzhou sites internal audit program and inspection readiness plan where required. 审核和评估新/修订的法规并且将其纳入DPS苏州工厂所需的的内部审核项目和检查准备计划

Collaborate with the Site functional teams to formulate responses to internal corporate or external audit observations including identification and implementation of corrective and preventive actions. Ensure effective and timely completion of all remediation actions. 与工厂职能部门合作制定对公司内部或外部审核的发现项包括识别和实施纠正和预防措施确保及时有效地补救措施

Ensure timely communication of all compliance risks (existing or potential) to the J&J Compliance teams and the DPS Suzhou site leaders.确保及时地将所有合规性风险现有的或潜在的传达给强生合规部门和DPS 苏州工厂负责人

Ensure timely and accurate reporting and publishing of internal and external audit metrics for DPS Suzhou. 确保及时准确地报告和公布DPS 苏州的内审和外审指标

Provide input on the classification of all external audits (i.e. Regulatory Agency / Health Authority inspections Notified Body audits and observations at DPS Suzhou site. 提供所有外部审核的分类信息如审计机构卫生局检查公告机构审核以及在苏州工厂的视察

Serve as a Subject Matter Expert as needed to support proactive or reactive responses to issues.根据需求担任主要项目专家以支持问题的主动或被动反应

Coordinate/conduct compliance training (i.e. GMP ISO13485 Data integrity GDP) as required. 根据需求协调/指导合规性培训如GMPISO13485数据完整性GDP

Coordinate and organize external audits and inspection readiness.协调和组织外部审核和审核准备

Monitor CURVE Database for Regulatory Inspection data accuracy and completeness.监测CURVE数据库以确保法规审核数据的准确性和完整性

Support implementation plans for regulatory changes including routinely monitoring and verification of implementation activities.支持法规变更的实施计划包括对实施活动的常规监管和验证

Support proactive compliance business strategies.支持积极主动的合规业务策略

Responsible for communicating business related issues or opportunities to next management level.负责将业务相关问题或机会传达给下一级管理层

For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable.对于那些监督或管理员工的人员如适用负责确保下属遵循与健康安全和环境实践相关的所有公司指南以及所有需要的资源都是可用的且状况良好

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