QA Manager质量保证经理

该职位来源于猎聘 QA Manager 质量保证经理 Department 部门: Quality 质量部 Location：上海临港工厂 / Shanghai Lingang Site Job Purpose 岗位目的

• Lead Quality Assurance for the new China Oral Health manufacturing site, with end-to-end accountability for designing, establishing and sustaining a fit-for-purpose, risk-based quality management system from project design and site qualification through licensing, commercial start-up and routine operations. 领导中国口腔健康产品新工厂的质量保证工作，端到端负责构建、建立并持续运行适用且基于风险的质量管理体系，覆盖从项目设计、工厂确认、生产许可准备到商业化启动及日常运营的全过程。
• Provide independent quality leadership to ensure that facilities, systems, suppliers, materials, manufacturing processes, testing, product disposition and post-market activities consistently protect consumers and meet applicable Chinese regulatory requirements, product registration/filing commitments and Haleon standards. 提供独立的质量领导，确保厂房设施、质量系统、供应商、物料、生产工艺、检验、产品处置及上市后活动持续保障消费者安全，并符合中国适用法规、产品注册/备案承诺及Haleon标准。
• As a member of the site quality leadership team, integrate quality and regulatory considerations into business and operational decisions, build organisational capability and inspection readiness, and foster shared quality ownership across functions to support reliable supply, continual improvement and long-term sustainable performance. 作为工厂质量团队管理成员，将质量与法规要求前置融入业务和运营决策，建设组织能力与持续检查就绪状态，推动各职能共同承担质量责任，以支持稳定供应、持续改进和长期可持续运营。 Key Responsibilities 主要岗位职责
• Translate applicable China oral health product and cosmetics requirements, product registration/filing commitments and Haleon standards into a proportionate site quality strategy, governance model and operating controls. Maintain independent quality decision-making, define accountabilities and escalate material risks to site leadership. 将中国适用的口腔健康产品及化妆品法规、产品注册/备案承诺和Haleon标准转化为与风险相称的工厂质量战略、治理机制和运行控制；保持质量决策独立性，明确职责，并向工厂管理层升级重大风险。
• Establish, operate and continuously improve an integrated QMS covering document and record control, training and competency, change control, deviations, investigations, CAPA, nonconforming product, complaints, self-inspection, management review, data governance, recall, business continuity, etc. Use trends and quality metrics to identify systemic risks and drive sustainable improvement. 建立、运行并持续改进覆盖文件与记录、培训与胜任力、变更控制、偏差、调查、CAPA、不合格品、投诉、自查、管理评审、数据治理、召回和业务连续性等的一体化质量管理体系；通过趋势和质量指标识别系统性风险并推动可持续改进。
• Own end-to-end operational quality assurance: Ensure quality requirements are embedded from supplier and material controls through compounding, filling, packing, warehousing, distribution and batch disposition. Provide risk-based floor presence and oversight of hygienic controls, contamination prevention, traceability, line clearance, process control and record review, with authority to stop operations or withhold release when quality or consumer safety may be impacted. 负责端到端现场质量保证：确保质量要求贯穿供应商与物料控制、产品配制、灌装、包装、仓储、配送和批次处置；基于风险开展现场支持与监督，覆盖卫生控制、污染预防、追溯、清场、过程控制和记录审核；当质量或消费者安全可能受到影响时，有权暂停作业或拒绝放行。
• Partner with Regulatory Affairs and technical functions to maintain alignment among formula and raw-material information, manufacturing process, product standards, labels, test reports, safety assessments, efficacy-claim evidence and registration/filing commitments. Integrate regulatory impact assessment into change control and ensure approved changes are implemented consistently at site. 与法规事务及技术职能协作，确保配方与原料信息、生产工艺、产品执行标准、标签、检验报告、安全评估、功效宣称证据和注册/备案承诺保持一致；将法规影响评估融入变更控制，并确保批准的变更在工厂得到一致实施。
• Set quality expectations and approve risk-based qualification and validation strategies for facilities, utilities, equipment, cleaning, processes, analytical methods and computerized systems. Ensure quality input is built into project decisions, commissioning, technology transfer, start-up and significant site changes rather than applied retrospectively. 设定质量要求并批准厂房、公用系统、设备、清洁、工艺、分析方法和计算机化系统基于风险的确认与验证策略；确保质量要求前置融入项目决策、调试、技术转移、启动及重大工厂变更，而非事后补充。
• Protect consumers and lead inspection readiness: Integrate complaint handling, adverse-reaction monitoring, signal escalation, field action and recall readiness into the site QMS. Lead regulatory and corporate inspection readiness, coordinate inspections and audits, ensure evidence-based responses, and verify that commitments and CAPAs address root causes effectively. 保护消费者并领导检查就绪：将投诉处理、不良反应监测、信号升级、市场行动和召回准备纳入工厂质量体系；领导监管及公司检查就绪，协调检查与审核，确保回复以证据为基础，并验证承诺事项和CAPA能够有效解决根本原因。
• Build team capability: Recruit, develop and lead a capable QA team with clear accountabilities and effective succession, creating an inclusive and empowering environment that strengthens engagement, ownership and performance. Act as the site’s quality partner and coach, enabling Production, Engineering, Laboratory, Supply Chain, Procurement and other functions to own quality in daily decisions while preserving appropriate QA challenge and oversight. Promote integrity, speak-up behavior and compliance with quality, EHS, legal and corporate requirements. 建设组织能力：招聘、培养并领导职责清晰、具备胜任力且有有效继任安排的QA团队，营造包容、充分授权的工作环境，持续提升团队敬业度、主人翁意识和工作绩效；作为工厂质量合作伙伴和教练，推动生产、工程、实验室、供应链、采购及其他职能在日常决策中承担质量责任，同时保持QA必要的挑战和监督；倡导诚信、主动发声，并遵守质量、EHS、法律法规及公司要求。 Specialized Knowledge and Experience 专业知识与经验
• Education 教育背景: Bachelor’s degree or above in cosmetics science, chemistry, biology, pharmacy, food science, public health or another relevant discipline. 化妆品科学、化学、生物、药学、食品科学、公共卫生或其他相关专业本科及以上学历。
• Experience 工作经验: At least 8 years of progressive experience in manufacturing quality, including at least 3 years in a people-management or site-quality leadership role. Direct experience in oral health, cosmetics, oral care, personal care, food or other hygienic consumer-product manufacturing is strongly preferred. Pharmaceutical experience is valuable when combined with demonstrated ability to apply proportionate cosmetics requirements rather than defaulting to pharmaceutical GMP. 至少8年制造质量相关经验，其中至少3年团队管理或工厂质量领导经验；优先考虑具有口腔健康、化妆品、口腔护理、个人护理、食品或其他卫生要求较高的消费品生产经验者。制药行业经验可作为优势，但候选人须证明能够按风险和口腔健康产品/化妆品法规要求实施适度控制，而非简单照搬药品GMP。
• Regulatory qualification 法规资质: Strong knowledge of China’s oral health product and cosmetics regulatory framework, production quality management requirements, product registration/filing, labeling, safety assessment, efficacy claims, adverse-reaction monitoring and recall requirements.

深入理解中国口腔健康产品及化妆品监管框架、生产质量管理、产品注册/备案、标签、安全评估、功效宣称、不良反应监测和召回要求。

• Technical capability 专业能力: Demonstrated expertise in QMS design, risk management, investigations and CAPA, supplier quality, contamination control, process and cleaning validation, computerized systems, data integrity, audit management and inspection readiness. Knowledge of oral health product formulation, mixing, filling and packaging controls is preferred. 具备质量体系设计、风险管理、调查与CAPA、供应商质量、污染控制、工艺与清洁验证、计算机化系统、数据完整性、审核管理及检查就绪方面的成熟能力；熟悉口腔健康产品配方、配制、灌装和包装控制者优先。
• Leadership and behaviors领导力与行为: Independent judgment, integrity, consumer focus, sound risk-based decision-making, strong influencing and cross-functional leadership skills, and the confidence to stop or withhold release when quality or consumer safety may be compromised. 具备独立判断、诚信、消费者导向和稳健的风险决策能力；具有较强的影响力和跨职能领导力；当质量或消费者安全可能受到影响时，有信心暂停生产或拒绝放行。
• Language and digital skills 语言及数字化能力: Fluent written and spoken Chinese and English; proficient in Microsoft Office and electronic quality/document management systems. Able to produce clear, accurate and inspection-ready records and reports in both languages. 中英文书面及口头沟通流利；熟练使用Microsoft Office及电子质量/文件管理系统；能够以中英文形成清晰、准确且可经受检查的记录和报告。