Senior Quality Specialist

Job description

Title: Senior Quality Specialist Company: Ipsen (Tianjin) Pharmaceutical Trade Co., Ltd About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram. Job Description: The Senior Quality Specialist is responsible for the management of GSP quality operations and oversight of the commercial quality system within Ipsen China. The role ensures that all activities related to pharmaceutical and medical device distribution licenses are conducted in compliance with applicable regulations, local GxP requirements, company policies, and procedures. The position also supports eDMS, eQMS, training system administration, continuous quality system improvement, and other duties assigned by the line manager. 高级质量专员负责益普生中国GSP质量运营管理及商业质量体系监督，确保药品及医疗器械经营许可证相关活动符合适用法规、当地GxP要求、公司政策及程序。该职位同时负责支持eDMS、eQMS及培训系统管理，推动质量体系持续改进，并完成直属经理安排的其他工作。 Main responsibilities / job expectations 主要职责： Quality Management质量管理: Organize creating quality management system documents, and guide, monitor their implementation. 组织质量管理体系文件的建立，并对其实施进行指导和监督。 Be responsible for the collection and management of regulation information, to ensure that the relevant personnel timely understand relevant published regulations and policies. 负责法规信息的收集与管理，确保相关人员及时了解已发布的法规和政策。 Participate in the self-inspection and risk assessment of quality management system. 参与质量管理体系的自查与风险评估。 Assist in quality management education and training. 协助开展质量管理相关的教育与培训工作。 Be responsible for the management of quality events and follow up investigations and related action plans to ensure timely completion. 负责质量事件管理，跟进调查及相关改进行动，确保按计划及时完成。 Be responsible for CAPA management and follow up corrective and preventive actions to ensure timely implementation and effectiveness. 负责CAPA（纠正与预防措施）管理，跟进相关措施的落实并确保其有效性 Be responsible for Change Control management, ensuring that impact assessments, risk evaluations, implementation plans, effectiveness checks, and change closures are completed in a timely and compliant manner. 负责变更控制（Change Control）管理，确保影响评估、风险评估、实施计划、有效性检查及变更关闭符合要求并及时完成。 Complete the tracking and trend analysis of quality events, change control, CAPA, etc. 完成质量事件、变更控制、CAPA 等事项的跟踪与趋势分析。 Support the implementation and continuous improvement of Quality Systems, including Change Control, CAPA, Deviations, Risk Management, Documentation Management, Training Management, and Management Review processes. 支持质量体系的实施与持续改进，包括变更控制（CC）、CAPA、偏差管理、风险管理、文件管理、培训管理及管理评审等质量体系流程。 Be responsible for the qualification review of suppliers, distributors, products, supplier sales personnel, and customer procurement personnel, and perform ongoing qualification management as the GSP Responsible Agent Responsible for Quality. 作为GSP质量机构负责人，负责供应商、客户、采购药品、供应商销售人员以及客户采购人员资质审核，并开展持续动态管理。 Support the audit and evaluation of the quality management system and service level of medicinal product suppliers and distributors. 支持对药品供应商和经销商质量管理体系及服务水平的审计与评估。 Be responsible for the review and maintenance of quality-related master data for products, suppliers, and distributors within SAP. 负责SAP系统中产品、供应商及客户质量主数据的审核与维护。。 Be responsible for blocking unqualified suppliers and distributors, as well as confirming qualified suppliers and distributors within SAP. 负责在 SAP 系统中冻结不合格的供应商和经销商，并确认合格的供应商和经销商。 Participate in the review of transport conditions and quality assurance capabilities for carriers. 参与对承运商运输条件及质量保障能力的评估。 Participate in the review of qualification conditions for storage service providers. 参与仓储服务供应商资质条件的审核。 Participate in periodic quality review for logistic storage service providers. 参与物流仓储服务供应商的定期质量回顾。 Act as the backup person for product traceability code management and provide support for CN30 and Dysport-related activities. 作为产品追溯码管理的后备人员，支持CN30及Dysport相关项目活动。。 Serve as e-QMS, DMS and Training (iLearn) Admin role for Quality Department. 担任质量部门 e‑QMS、DMS 及培训系统（iLearn）的系统管理员。 Act as one of the licensed pharmacists required by the pharmaceutical distribution license and perform relevant regulatory responsibilities in accordance with applicable regulations. 作为药品经营许可证要求配置的执业药师之一，依法履行相应法规职责。 Perform other duties assigned or delegated by line manager, e.g. supplier quality on-site audit. 完成上级经理分配或委托的其他工作，如供应商现场质量审计。 Collaboration with other Departments部门协作 Proactively advocate for quality processes across functions 主动在各职能领域倡导质量流程。 Proactively identify areas for process improvement and mediate cooperation cross-functionally to effect and implement the Quality System. 主动识别流程改进领域，并跨职能协调合作以实施质量体系。 Contribute towards stakeholder value by providing quality leadership and operational input towards Ipsen China strategic and tactical activities. 通过益普生中国公司战略和战术活动提供质量领导力和运营输入，为利益相关者创造价值。 Communication沟通 To respect and apply the company rules (especially the confidentiality ones) and strategy in communication with media, authorities, and health professionals. 在与媒体、当局和卫生专业人员沟通时，尊重并执行公司规则（尤其是保密规则）和战略。 To provide scientific information about Ipsen products, whenever requested by members of the medical or pharmaceutical community or by customers or patients. 根据医疗或制药界成员、客户或患者的要求，提供有关 Ipsen 产品的科学信息。 To act with all relevant authorities/entities, with a great sense of public relations, having in perspective an increased efficiency and recognition of Ipsen. 与所有相关当局/实体合作，具有很强的公共关系意识，着眼于提高 Ipsen 的效率和知名度。 To maintain and develop positive and ethical interactions with relevant authorities. 维护并发展与相关当局的积极且符合道德的互动。 To respect and apply the IPSEN ethical code. 尊重并执行 IPSEN 道德准则 To develop a deep knowledge of company products. 深入了解公司产品。 Knowledge, abilities & experience知识、能力和经验 Education and Experience教育和经验: Major of Pharmaceutical Sciences, or related areas 药学或相关专业 Bachelor’s degree or above 本科或本科以上学历 Registered Pharmacist License (China) is required. 具备中国执业药师资格 Minimum 5 years of experience in the pharmaceutical or related industry 具备至少5年医药行业或相关行业工作经验. Minimum 3 years’ experience in drug GSP quality management. 具备不少于3年药品经营 (GSP)质量管理工作经验。 ISO Auditor Certification is preferred. 持有ISO审核员资格证书者优先 Technical Skills Requirements 技能要求: Familiar with government affairs and regulatory processes relevant to the pharmaceutical industry. 熟悉医药行业相关政府事务及监管流程 Strong knowledge of applicable GMP, GDP and GSP regulations is required. 熟悉适用的GMP、GDP及GSP法规要求 Strong communication, stakeholder management, and influencing skills 具备优秀的沟通协调能力、利益相关方管理能力及影响力 Good teamwork spirit良好的团队合作精神 Good command of written and spoken English, e.g.CET-4 level or above. 具备良好的英语听说读写能力，大学英语4级或以上 We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information w