天津招聘

岗 位 职 责(包括职权、具体工作职责、工作任务等)：

? Be responsible for generating, maintaining and improving Quality Management System (QMS) for Henlius clinical development, including policy/standard, SOP and working instruction, etc.

? Management of the QMS documents (Creation, translation, distribution, checking, updating and destroy)

? Be an expert on local regulations and international guidelines – Provides interpretation and gives direct input into the QMS. Monitor external regulatory landscape and lead internal efforts to conduct gap analysis. Communicates changes to local regulation to business customers/partners.

? Design overall quality related training strategy and implement the training program in collaboration with key business partners and quality internal team members.

? To conduct training to clinical staffs for clinical research regulations and QMS requirements. Involve in GCP inspection by provide inspection practice training

? Ensures SOPs are well understood across the clinical development team; leading and providing clarification on local implementation. Ensure that all defined QMS processes are effectively deployed and continually kept up. Evaluate implementation and provide feedback for assessment of ongoing effectiveness of the QMS.

? Support implementation of quality system locally by providing interpretation of requirements when consulted.

? Management of the SOPs (Creation, translation, distribution, checking, updating and destroy)

? Maintain and improve procedures to ensure industry standards and regulatory requirements.

任 职 条 件（包括学历、专业、从业经历、能力特点等）：

? Bachelor degree or higher (in pharmaceutical, medical or other relevant biological science)

? Experience in clinical research (min. 6 yrs) & quality system management or quality control

? Experience in leading design QMS for clinical development

? Proficient at English and MS office softwares

    复宏汉霖（*******）是一家国际化的创新生物制药公司，旨在为全球患者提供质高价优的创新生物药，产品覆盖肿瘤、自身免疫性疾病等领域。自2010年成立以来，公司以全球联动、整合创新为产品开发理念，在中国上海、中国台北和美国加州均设有研发中心，具备了协同增效的突出优势。复宏汉霖主要的产品开发策略是仿创结合，从生物类似药起步，逐步开发创新型单抗产品，结合自主开发的抗PD-1和PD-L1单抗，在国内率先推出免疫联合疗法，前瞻性布局了一个多元化、创新单抗及肿瘤免疫联合疗法管线，打造出研究、开发、商业化生产的综合性生物医药全产业链平台。

    截至目前，复宏汉霖已有1个产品成功上市，2个产品获得中国新药上市申请受理，1个产品获得欧盟营销授权申请受理，10个产品、8个联合治疗方案在全球范围内开展20多项临床试验。其中，公司首款重磅产品汉利康？（利妥昔单抗注射液）于2019年2月获国家药监局新药上市注册批准，成为中国***获批上市的生物类似药。HLX03（阿达木单抗注射液）与HLX02（注射用曲妥珠单抗）已获国家药监局新药上市申请受理，现已纳入优先审评程序。HLX02相继在中国大陆、乌克兰、欧盟波兰和菲律宾全面启动国际多中心3期临床试验，成为国内***开展国际多中心3期临床研究的生物类似药，并于2019年6月获欧洲药品管理局营销授权申请受理。此外，公司已陆续就HLX10（抗PD-1单抗）与自有产品HLX04（贝伐珠单抗生物类似药）、HLX07（抗EGFR单抗）以及化疗联用开展多项肿瘤免疫联合疗法，在全球范围内开展多个临床研究。