Oral Site Quality Lead

Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity.

Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.

Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.

工作职责

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 purpose and in good operating condition.

5. 供应商及委托活动 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.

• 批准并监督委托生产和委托检验活动，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.

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。
  Set a high standard for quality and compliance culture across the site, ensuring quality and compliance risks are systematically identified, managed or mitigated.

• 有权就工厂生产产品的质量和合规事项作出独立决定；重大质量事项应按照公司升级流程上报至适当管理层。
  Have authority to make independent decisions on quality and compliance matters related to products manufactured at the site; significant quality matters shall be escalated to the appropriate management level in accordance with Company escalation processes.

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.

• 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.

• 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.

ommon office software.

 Job Posting End Date

Equal Opportunities

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong.

During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees. 

The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.

Adjustment or Accommodations Request

If you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific adjustments you are requesting. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence. 

Note to candidates

The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.