上海招聘

PURPOSE
As Quality Manager, this role is responsible for the following key tasks/activities in China LOC.


RESPONSIBILITIES
60% of Time    Key Responsibilities
Management of Quality System:
？    Support to Implement and maintain local quality system applying to GxP activities related to storage, distribution and
 commercialization of all products under development or marketed by Takeda or through partnership agreements, in compliance with Takeda Quality reference standards.
？    Enhance quality culture & promote Quality mindset into the LOC level, working principles and ways of operating.
？    Ensure appropriate communication of key messages pertaining to quality across the local organization, highlighting their possible business impact
？    Deviation and CAPA Management
？    Change Control Management
？    GxP Documentation and data Management
？    China LOC Audits and GxP Regulatory Inspections
？    Provide support to ensure continuous audit and inspection readiness,
？    Manage country regulatory inspections related to GxP processes owned by LOC QA
？    Assure that inspections of GxP or health-regulated areas are reported by LOC QA in the appropriate company global database
？    Define and implement a strategy for local audits based on risk management criteria, of key local GxP and health-regulated subcontractors directly managed by China LOC. Assure the coordination of the execution of the annual audit plan.
？    Evaluate trends in local quality audit findings that may affect LOC quality system and communicate to appropriate global functions the audit finding that require improvement.
？    Act as the primary China LOC contact for GxP system quality audits and support Global Quality Audit team in their preparation, conduct and follow-up
？    Organize and follow up quality councils according to global Takeda requirement.
？    Quality Agreement
Ensure that valid and signed quality agreements (with the country as contract giver) are in place for all GxP activities under the responsibility of Quality

？    Ensure that quality risks are properly managed within LOC China (identification, assessment, control, communication) , cooperate with relevant oversea manufacturing sites to handle all quality issues
？    Communicate with NIFDC and other technical institute for quality topic if need
？    Technical support work involved in receipt, release, storage and distribution of imported products,
？    Training management
Organize and manage information sharing, training sessions or programs related to processes owned by QA, according to Takeda standards and regulatory requirements
？    Quality Oversight of locally managed GxP Supplier:
Ensure and appropriate quality oversight process of locally managed subcontractors for GxP activities, either directly (being involved in selection process, support qualification and performance of audits) or through coordination with the concerned other functions (as appropriate)

20%    Management of Products Quality
？    Support Product Release, Product Return, Product Recall and Redressing activities for all products to ensure the compliance of GMP, GDP standard, company’s requirements and relevant regulatory requirements.
？    Product Complaints (PCs)
？    Manage product complaints received by the country according to Takeda processes, standards and appropriate tools in force, in connection with the concerned Global Quality function
？    Product related Quality Events
？    Escalate quality events as necessary occurring at the local level according to defined processes and standards and manage subsequent quality alerts (as appropriate)
？    Provide support to the appropriate functions at local level and according to the defined responsibilities vis a vis regulatory Authorities (e.g. Qualified Person, Regulatory Affairs to manage notification and communication with Regulatory Authorities for product related quality events)
Quality Intelligence Monitoring and Analysis
Ensure to implement GDP related requirements from local regulations properly within LOC China, cooperate with relevant stakeholders, either directly (being involved in selection process, support qualification and performance of audits) or through coordination with the concerned other functions (as appropriate)
.
20%    ？    Provide Quality technical supports timely to local business projects and new products launch projects
？    Other assigned work

KEY RELATIONSHIPS
Internal    Global/ regional QA team, Takeda sites, CMO, SC, Commercial, RA and PV
External    SIFDC/NIFDC/GDIDC, other local authorities, Importer, supplier, 3PL warehouse, customers

职位要求：
QUALIFICATIONS
Level of Education: Bachelor’s degree or above majored in Biology, Microorganism, Medicine, or Chemistry in Pharmacy, Master degree is perferred.
Working Experience in Relevant Field: At least 5 year working experience in pharmaceutical industry, preferable in MNCs
Experience in communication with health authorities, industry associations
Experience in quality management, preferable in QC/GMP/GDP.
Project management experience
Fluent in Chinese and English speaking and writing
Professional Knowledge and Skills    Fluent in Chinese and English speaking and writing, “Can Do” attitude, strong sense of responsibility, good execution, professional quality and dedication; Strong adaptability and internal and external communication ability, good computer skills, proficient in office software

武田成立于1781年，最初是由武田长兵卫（Chobei Takeda）开创的一家在大阪经营日本和中国传统草药的店铺。1871年，武田长兵卫四世开始进口“西药”。从那时起，武田逐渐成长为一家集研发、制造和营销为一体的现代化企业。2009年，武田药品工业株式会社进行重组，从一家具有全球业务的日本制药公司转变为一家将总部设在日本的全球化制药企业。2011年，武田收购了奈科明公司及奈科明与上海医药合资的天普药业，进一步拓宽了武田在全球，尤其是中国市场的进口、分销和客户服务网络。
在创立230多年后的今天，武田在全球拥有约30,000名员工，业务和运营覆盖超过70个国家和地区。每年，武田将全球总营业额的大约20%投入研发。超过700个产品覆盖六大关键治疗领域：心血管与代谢、肿瘤、呼吸与免疫、中枢神经系统、普药、疫苗，销往全球90多个国家和地区。
武田的国际品牌标志代表一座桥梁，象征着武田连接起***突破和满足病患需求的诊疗方案，也象征着武田和医疗保健服务密切相关的病患、医生等社会成员紧密联系。“武田主义”是武田的企业理念之本，是在其所有运营活动中坚守的核心价值。武田承诺，在任何时候，尤其是面对困难与挑战时，公司都奉行以公平、正直和坚毅为基础的“诚信”准则。
武田为成为一家真正的全球化制药企业而不断努力，希望能提供满足各种各样医疗需求的解决方案，为全世界人们的生命健康和美好未来做贡献。