Quality Director质量总监

该职位来源于猎聘 Quality Director 质量总监 Location: 上海临港工厂 / Shanghai Lingang Site 责任范围 AREAS OF RESPONSIBILITY 1. 质量领导与治理 Quality Leadership and Governance

• 领导工厂质量团队，就质量和合规事项为工厂提供方向性指导。 Lead the site Quality team and provide direction to the site on quality and compliance matters.
• 代表质量职能参加工厂管理会议及其他重要互动，确保质量观点纳入重大决策。 Champion the interests of Quality in site management meetings and other key interactions, ensuring quality considerations are incorporated into significant decisions.
• 有效管理工厂质量委员会及其他质量治理机制，确保质量和合规风险得到及时识别、升级、管理和缓解。 Effectively manage the Site Quality Council and other quality governance processes to ensure timely identification, escalation, management and mitigation of quality and compliance risks.
• 确保建立及时有效的质量问题沟通和升级流程。 Ensure timely and effective communication and escalation processes are in place for quality issues. 2. 质量管理体系 Quality Management System
• 确保适用的GMP、公司质量标准、SOP及相关政策在工厂得到有效实施。 Ensure effective implementation of applicable GMP, Company Quality Standards, SOPs and relevant policies at the site.
• 确保建立并维护高效、以技术和风险为基础的质量管理流程，包括变更、偏差、投诉、OOS、CAPA、审计及文件管理。 Ensure efficient, technically sound and risk-based quality processes are established and maintained, including change control, deviation, complaint, OOS, CAPA, audit and document management.
• 审核和批准所有与质量相关的变更，确保影响评估、实施行动、有效性检查和关闭活动充分且及时。 Review and approve all quality-related changes, ensuring impact assessments, implementation actions, effectiveness checks and closure activities are adequate and timely.
• 持续评估质量体系绩效，推动流程改进、一次做对和合规文化建设。 Continuously evaluate QMS performance and drive process improvement, right-first-time execution and a strong compliance culture. 3. 产品质量与批放行 Product Quality and Batch Release
• 确保原辅料、包装材料、中间产品、待包装产品和成品符合批准的注册要求及质量标准。 Ensure raw materials, packaging materials, intermediate products, bulk products and finished products comply with approved registration requirements and quality standards.
• 确保产品放行前完成批记录、检验结果、偏差及其他相关信息的合规审核，并维持高效、合规的批放行流程。 Ensure compliant review of batch records, test results, deviations and other relevant information prior to product release, and maintain an efficient and compliant batch release process.
• 负责或确保产品放行决定基于已批准的生产、检验、注册要求和产品质量标准，并保存相关记录。 Be responsible for, or ensure, product release decisions are based on approved manufacturing, testing, registration requirements and product quality standards, with appropriate records retained.
• 批准质量标准、取样方法、检验方法及其他质量管理操作规程。 Approve quality standards, sampling methods, test methods and other quality management procedures.
• 确保重大偏差、OOS和产品质量投诉得到充分调查、及时处理，并参与召回及其他质量管理活动。 Ensure significant deviations, OOS results and product quality complaints are adequately investigated and timely managed, and participate in recalls and other quality management activities.
• 确保产品持续稳定性考察计划完成并获得适当数据。 Ensure completion of the ongoing stability program and availability of appropriate stability data.
• 确保完成产品质量回顾和趋势分析。 Ensure completion of product quality reviews and trend analyses. 4. 验证、设施与设备 Validation, Facilities and Equipment
• 确保建立适当体系以完成所有必要的确认和验证。 Ensure appropriate systems are in place for all necessary qualification and validation activities.
• 审核和批准确认或验证方案及报告。 Review and approve qualification or validation protocols and reports.
• 监督厂房、设施和设备的维护，确保其保持适用和良好的运行状态。 Oversee maintenance of premises, facilities and equipment to ensure they remain fit for purposes and in good operating condition. 5. 供应商对接活动 Supplier and Contracted Activities
• 确保建立物料供应商资格评估、批准和持续监控体系。 Ensure systems are established for qualification, approval and ongoing monitoring of material suppliers.
• 评估和批准物料供应商，并确定和监控物料及产品的贮存条件。 Assess and approve material suppliers and determine and monitor storage conditions for materials and products.
• 批准并监督生产和检验活动，确保质量协议、职责界面、变更、偏差和绩效管理得到有效控制。 Approve and oversee contract manufacturing and contract testing activities, ensuring effective control of quality agreements, responsibility interfaces, changes, deviations and performance management. 6. 法规符合性 Regulatory Compliance
• 与法规事务职能合作，监督工厂产品注册及工厂发起的注册相关变更，确保产品和生产活动符合适用的批准要求。 Work with Regulatory Affairs to oversee site product registrations and site-initiated registration-related changes, ensuring products and manufacturing activities comply with applicable approved requirements.
• 确保工厂持续保持检查准备状态，并支持监管机构检查及公司审计。 Ensure the site maintains continuous inspection readiness and supports Health Authority inspections and Company audits. 7. 审计与CAPA Audit and CAPA
• 有效管理内外部审计和检查计划，确保主要或关键发现得到适当调查并制定充分的CAPA。 Effectively manage internal and external audit and inspection programs, ensuring major or critical observations are appropriately investigated and adequate CAPAs are established.
• 定期监控CAPA进度、有效性及按期关闭情况，并将重大风险及时升级。 Periodically monitor CAPA progress, effectiveness and on-time closure, and escalate significant risks in a timely manner. 8. 培训与人员发展 Training and People Development
• 领导和推动工厂合规培训体系，确保员工胜任岗位并具备适当资质。 Lead and drive the site compliance training system to ensure employees are competent and appropriately qualified.
• 负责质量团队人才发展、员工敬业度和能力建设，并确保关键岗位继任计划落实。 Be responsible for talent development, employee engagement and capability building within Quality, and ensure succession plans are in place for key roles.
• 建设能够作出适当质量决策的高效质量团队。 Develop an effective Quality team with the capability to make appropriate quality decisions. 9. 风险、绩效与资源 Risk, Performance and Resources
• 负责质量职能风险管理，包括主动识别、评估风险并制定缓解行动。 Be accountable for functional risk management, including proactive risk identification, assessment and mitigation planning.
• 建立并持续监控适当的质量绩效指标，确保行动按期推进和落实。 Establish and continuously monitor appropriate quality performance indicators, ensuring actions are progressed and completed on time.
• 负责部门年度预算并有效配置资源，以支持质量、合规和业务目标。 Own the annual department budget and deploy resources effectively to support quality, compliance and business objectives. 10. EHS及其他职责 EHS and Other Responsibilities
• 理解并遵守适用的EHS法律法规、公司标准、政策及安全作业程序。 Understand and comply with applicable EHS laws and regulations, Company standards, policies and safe work procedures.
• 及时报告不安全状况、工伤、疾病和危险物料泄漏，并支持工厂EHS管理体系。 Promptly report unsafe conditions, injuries, illnesses and hazardous material releases, and support the site EHS management system.
• 完成直线经理安排的其他项目和任务。 Perform other projects and tasks assigned by the line manager. 任职要求 MINIMUM REQUIREMENTS 教育背景与经验 Education Background and Experience
• 本科或以上学历，药学、制药、生物或相关科学专业。 Bachelor’s degree or above in Pharmacy, Pharmaceutical Science, Biology or a related scientific discipline.
• 具有10年以上产品生产、质量管理或技术运营相关经验，并具备质量保证和质量控制实践经验；或经工厂评估具备同等知识、能力和资质。 More than 10 years of relevant experience in product manufacturing, quality management or technical operations, with practical experience in Quality Assurance and Quality Control; or equivalent knowledge, capability and qualification assessed by the site.
• 具有质量体系审计、监管检查或检查准备相关经验。 Experience in quality system auditing, regulatory inspection or inspection readiness.
• 具备项目管理、计划制定和组织协调经验。 Experience in project management, planning and organization. 专业知识与技能 Special Knowledge and Skills
• 熟悉GMP、QMS、公司质量标准及适用法规要求。 Familiar with GMP, QMS, Company Quality Standards and applicable regulatory requirements.
• 具有较强的领导力、团队管理、计划、沟通和协调能力。 Strong leadership, team management, planning, communication and coordination skills.
• 具有良好的分析、风险判断、决策和问题解决能力。 Strong analytical, risk-based judgment, decision-making and problem-solving capability.
• 能够识别持续改进机会并推动其在组织内落地。 Ability to identify continuous improvement opportunities and drive execution across the organization.
• 能够熟练使用计算机和常用办公软件。 Proficient in the use of computers and common office software.
• 英语听说读写良好，能够开展跨区域的专业沟通。 Good command of written and spoken English, with the ability to communicate professionally across regions. 责任与决策权限 ACCOUNTABILITY AND DECISION AUTHORITY
• 在整个工厂建立高标准的质量和合规文化，确保质量与合规风险得到系统识别、管理或缓解。