北京招聘

Major Responsibilities and Duties:

1. Coordinate and participate the GMP and GCP vendor qualification audits, follow up to ensure the audit findings’ close out and CAPA implementation, maintain the approved vendor list with periodical reviews.

2. Develop and maintain the site quality management system and procedures, ensure the successful regulatory inspections from Health Authorities.

3. Provide quality oversights of company’s CRO/CMO, managing quality agreement with these partners, and quality related events including major deviations, investigations.

4. Work closely with CMC team, provide support for material sourcing management, and supplier evaluation and risk assessment.

5. Provide quality oversight of GCP QC team, and work closely with clinical operation team to ensure data integrity and data traceability.

6. Responsible for the site training management, develop site training plan, training materials and provide trainings.

7. Responsible for the GxP document management including archiving.

Qualifications:

1. Bachelor of Science or above in medical or pharmacy or a life/biological science or quality-related field, or equivalent combination of education, training and experience.

2. At least 3 years working in pharmaceutical industry and demonstrated expertise of GxP and regulatory requirements, as well as analytical, organizational and planning abilities.

3. Thorough understanding of QMS and Quality Risk Management (QRM) for pharmaceutical company. Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.

4. Excellent/accomplished communication skill, facilitation, and strategic thinking skills within the organization, good at data analysis and presentation.

5. Able to work in a team as well as to work independently with limited guidance or supervision.

6. Good English(written and spoken) and Chinese.

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。