Quality Compliance Management

**About Us:** Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.   Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at [www.opella.com](http://www.opella.com/). **Mission & Tasks** **使命与任务** Opella’s ambition is to revolutionize self-care. Quality is everyone’s responsibility in our “Health in Your Hands” mission, making selfcare as simple as it should be. 欧彼乐致力于在 “自我健康管理” 领域引领变革。在欧彼乐 “健康在握” 的使命中，质量是每个人的职责所在，让自我健康管理变得触手可得。 The Quality Manager plays a critical role in maintaining and enhancing Opella China's Quality Management System. This position is responsible for ensuring compliance with GxP regulations, company standards, and industry’s best practices across all operations. The role involves executing quality processes, conducting inspections, managing documentation, and supporting continuous improvement initiatives to deliver trusted healthcare solutions to patients and consumers. 质量经理在维护和提升欧彼乐中国质量管理体系方面发挥关键作用。该职位负责确保所有运营活动符合GxP法规、公司标准和行业最佳实践。该岗位涉及执行质量流程、开展检查、管理文档，并支持持续改进计划，为患者和消费者提供值得信赖的医疗保健解决方案。 ·        Quality System Management质量体系管理 ·        Quality and Regulatory Conformity 药品经营质量管理规范法规合规 ·        Audit and Inspection审计与检查 * Cross-functional Collaboration 跨职能协作 **Scope of Responsibility** **职责范围** **Management Responsibilities:** 1\. Quality System Management 质量体系管理： 1.1            Quality System Implementation 质量体系实施 Implement and maintain quality systems for pharmaceutical products in compliance with regulatory requirements and company standards. 贯彻和维药品的质量体系，确保符合法规要求和公司标准。 1.2            Self-inspection (Internal Assessment, IA) 内部审核 \-           Ensure internal assessments are conducted regularly according to schedule and necessary corrective/preventive measures are implemented. 确保内审按计划定期开展，并实施必要的纠正/预防措施。 \-           Ensure compliance to the GSP requirements for self-inspections. 确保符合GSP自检要求。 \-           Ensure that warehouse environment and operations where Opella products are stored and distributed meet both GSP and Opella standards through periodic self-inspections and continuous improvement 通过定期自检和持续改进，确保欧彼乐产品储存和配送的仓库环境和运营符合GSP和欧彼乐标准 1.3            Deviation & CAPA Management偏差与CAPA管理 \-           Ensure that a process to timely manage deviations and CAPAs related to all GxP activities across the country is in use. 确保及时管理与国内所有GxP活动相关的偏差和CAPA的流程得到使用。 \-           Implement CAPA to address deviations/non-conformities. 实施纠正和预防措施(CAPA)以解决偏差/不符合项。 1.4            Additional Responsibilities 其他职责 Complete additional tasks and assignments as required to support business objectives. 完成支持业务目标所需的其他任务和指派工作。 2\. Quality and Regulatory Conformity 药品经营质量管理规范法规合规： 2.1    QMS Establishment & Maintenance for GSP（MAH Downstream） 建立与维护药品经营质量管理规范质量体系和MAH下游质量管理体系 Ensure that a Quality Management System linked to GSP activities（MAH downstream activities） is implemented and maintained. 确保与GSP活动（或MAH公司下游质量活动）相关的质量管理体系得到实施和维护。 2.2    Quality Risk Management质量风险管理 \-           Implement Quality Risk Management to identify, assess and control quality risks. 实施质量风险管理，识别、评估和控制质量风险。 \-           Responsible for Transportation qualification and risk assessment 负责运输确认和运输风险评估。 2.3    Supplier & Customer Qualification Management 供应商与客户资质审核 \-           Review qualification and approval of suppliers/vendors and customers(related to GxPs), master data management under quality. Ensure that all GSP suppliers (internal or subcontractors) are qualified with a process to ensure regular check and oversight. 审核、确认并批准供应商和客户(关于GxP 等)，以及负责质量职责下的主数据管理。确保所有GDP供应商（内部或分包商）经过资质确认，并定期检查和监督。 \-           Support quality master data management for suppliers, vendors, and customers to ensure data accuracy and compliance. 支持供应商、服务商及客户的质量主数据管理，确保数据准确性和合规性。 2.4    Product Disposition (Support) 产品处置 Release/authorize the distribution of the batch to the market based on the manufacturing batch disposition decision and relevant additional information as per local regulations. 根据生产批次处置决定和当地法规要求的相关补充信息，释放/授权批次向市场分销。 2.5    Returns, rejected, or recalled products 退货、不合格品及召回管理 \-           Approve（Authorized Approval） any return to saleable stock 批准（或授权批准）任何退回可销售库存的产品 \-           Ensure Investigation of Non-conformance, being involved in any decision to quarantine or dispose of returned, rejected, or recalled products 确保不合格的调查，介入对所有相关退货，不合格，以及召回产品进行隔离或处置的决策。 \-           If destruction: approval, witnessing if physical presence needed, records keeping (documentation) \-           如需销毁：批准、必要时现场见证、记录保存（文件） \-           Implement drug recall decisions and complete the execution and reporting of recalls in compliance with GSP/GMP(Applicable) requirements. \-           贯彻药品召回决策，并遵循GSP/GMP（等适用法规）要求完成药品召回的实施、报告 2.6    Third Party Management外部合作方管理 \-           Collaborate with relevant partners to ensure compliance of consumer drugs sectors with Global Guidelines and Policies, including enterprise standards related to Quality and Regulatory Compliance for delivery. 与相关合作伙伴协作，确保药品领域符合全球指南、政策及与质量和法规合规相关的企业标准要求。 \-           Ensure Distribution Centers (DCs) comply with GDP/GSP requirements for drugs. 确保配送中心符合药品的GDP/GSP要求。 \-           Participate in qualification, monitoring and evaluation of third parties. 参与外部合作方的资质审核、监督管理和评估。 \-           Collaborate with cross-functional teams during new product development to identify quality and regulatory compliance risks, develop mitigation actions, and ensure timely product launch. Support NPD/NPI processes and drive compliant business growth. 在新产品开发中与跨职能团队合作，识别质量和法规合规风险，制定缓解措施，确保产品按时上市。支持NPD/NPI流程，推动业务合规增长。 2.7    Product Complaint Management 产品投诉管理 \-           Owning Product Technical Complaints (PTC) and Product Specific Feedback (PSF) for drug products, including registration, translation, investigation, closure, and reporting. \-           负责药品的产品技术投诉（PTC）和产品特定反馈（PSF），包括登记、翻译、调查、关闭及报告 \-           Responsible for complaints and conduct root cause analysis, formulate and implement corrective/preventive actions (CAPA) to prevent recurrence of problems. \-           负责处理质量投诉并开展根本原因分析，制定并实施纠正/预防措施（CAPA），以防止问题再次发生。 2.8    Drug Traceability Management 药品追溯管理 Conduct drug traceability inspections and verifications to ensure full compliance and effectiveness of traceability systems. 开展药品追溯检查与复核，确保追溯系统的合规性和有效性。 3\. Audit and Inspection 审计与检查： Participate in the preparation and implementation of internal and external audits and inspections. 参与内外部审计与检查的准备及实施工作。 4\. Cross-functional Collaboration 跨部门协作：        Support and coordinate post-marketing quality activities related to the MAH 协助并协调MAH公司有关的下游质量事务 **Latitude of Action** **行动自由度：** ·        Monitor and enforce quality standards compliance, promptly reporting any non-conformances to the Country Quality Head with root cause analysis and recommended corrective actions. 监控并执行质量标准合规性，在发现任何不符合项时及时向国家质量负责人报告，并提供根本原因分析和建议的纠正措施。 ·        Investigate and resolve quality events in accordance with company procedures, escalating urgent cases, significant events, or adverse trends to the Country Quality Head with comprehensive impact assessments. 按照公司程序调查并解决质量事件，在紧急情况、重大事件或不良趋势出现时，向国家质量负责人上报并提供全面的影响评估。 ·        Proactively monitor regulatory developments and intelligence, analyze potential impacts on operations, and provide consolidated reports with actionable recommendations to the Country Quality Head. 主动监控法规动态和情报，分析对运营的潜在影响，并向国家质量负责人提供包含可执行建议的综合报告。 ·        Review and update Quality Agreements to define appropriate latitude of action for third parties, ensuring they can perform routine quality activities independently while maintaining oversight for critical decisions affecting product quality and compliance. 审核并更新质量协议，明确第三方的适当行动自主权，确保其能够独立执行常规质量活动，同时对影响产品质量和合规的关键决策保持监督。 **Role Impact** **岗位影响****:** The Quality Manager contributes to Opella China's Quality Management System by supporting the implementation and maintenance of comprehensive quality processes across the entire product lifecycle, ensuring all GxP activities consistently comply with regulatory requirements and company standards. 质量经理通过支持全面质量流程在整个产品生命周期中的实施和维护，为欧彼乐中国质量管理体系做出贡献，确保所有GxP活动始终符合法规要求和公司标准。 **Scope** **岗位范围****:** This role collaborates with Opella China staff across multiple functions and may engage with external service providers as required to support quality management initiatives. 该职位与欧彼乐中国各职能部门的员工进行协作，并在必要时与外部服务供应商合作，以支持质量管理计划。 **Required Experience** **任职要求**          Bachelor's degree or above in Pharmaceutical Sciences, Chemistry, Bioengineering, Life Sciences, or other relevant scientific disciplines (Must). 制药科学、化学、生物工程、生命科学或其他相关科学学科的本科及以上学历。（必须）          5 years plus working experience (include at least 1 year in GSP) in pharmaceutical industry, preferably in MNCs. 具有5年以上药企工作经验（其中至少1年GSP经验），跨国公司（MNCs）工作经验者优先。     Licensed pharmacist qualification (Preferred)        具有执业药师资格。（优先） **Required Skills** **技能要求**     Technical Competencies 技术能力 Ø  Strong analytical thinking and problem-solving capabilities. 较强的分析思维和问题解决能力。 * Hands-on troubleshooting skills with practical application experience. 具备实际应用经验的动手故障排查技能。 Ø  Proficiency in risk assessment and root cause analysis methodologies. 熟练掌握风险评估和根本原因分析方法。 Ø  Internal and External Audit experience. 内部和外部审计经验。     Personal Attributes 个人素质 Ø  Proactive mindset with a “can-do” attitude and good sense of responsibility. 具备积极主动的工作心态，拥有敢于挑战、勇于担当的精神和强烈的责任意识。 * Ability to work effectively under pressure and in complex matrix environments. 能够在压力下和复杂矩阵式组织环境中有效工作。 Ø  Strong adaptability and resilience in dynamic situations. 在动态环境中具有较强的适应性和韧性。     Language Requirements 语言要求 Fluent in English (reading and writing); strong communication skills preferred. 英语读写流利；具备较强的沟通能力者优先。