北京招聘

1)    Support to maintain, improve, and implement clinical QMS, including but not limited to:
?    Create, review, revise control documents according to regulatory requirements and pharmaceutical industry guidelines such as ICH-GCP, etc;
?    Ensure roles and responsibilities clearly defined in all sub-functional activities and specified in control documents;
?    Ensure proper records and documentation management;
?    Coordinate and manage deviations, change controls, CAPAs and effectiveness verification
2)    Host regulatory agency inspections and provide responses to audit report findings after discussion with operations management
3)    Lead and oversee the training program and collaborate with function teams to ensure staff training is current as required by their role.  Conduct GCP training at least annually and serve as mentor to junior team members
4)    Review and approve computer system validation (CSV) documents to ensure compliance with regulatory requirements
5)    Plan and conduct regular and random internal, investigational site, and vendor audits to assure that clinical studies are in compliance with the SOPs, study protocol, relevant regulations and guidelines;
6)    Perform quality system audits if required; Track and trend audit findings, investigations, assess compliance risk.
职位要求：
1)    Bachelor’s degree or equivalent in medical or pharmacy or a life/biological science or quality-related field, or equivalent combination of education, training and experience;
2)    Previous experience in Quality Assurance auditing and/or proven clinical research experience;
3)    Detailed knowledge of GCP guidelines and relevant regulations for the conduct of clinical trials;
4)    Communication and interpersonal skills, ability to liaise with project teams;
5)    Good understanding of drug development and clinical trial process.

Zai Lab is an innovative biopharmaceutical company based in Zhang Jiang, Shanghai focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab focus on innovation to meets the unmet medical needs. Zai has built up a strong pipeline with multiple programs on clinical stages. Zai Lab successfully listed on Nasdaq in Sep. 2017.

再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。