南京招聘

Role Description

Develops, maintains, and oversees the GCP quality management system (QMS), internal SOP for clinical development activities in Legend.

Develop QA plan and conducts audits of clinical trial sites, contract research organizations (CRO), suppliers, protocols, investigator brochures (IB) and study reports and reports all audit observations to clinical sites and Legend management. Conducts system and process audits as required, e.g. pharmacovigilance, data management, and safety.

Maintains GCP regulatory compliance and quality performance within Legend. Responsible for communicating quality issues to internal stakeholder, including resource requirements to maintain QA compliance. Prevent and mitigate quality risks that can jeopardize Legend interests (patient safety, supply continuity, reputation).

Key Responsibilities:

1. Develops, maintains, and oversees the GCP quality management system (QMS) and associated strategy, processes, tools, and technologies for clinical development activities

2. Develop clinical development cross function SOPs in collaboration with vendors

3. Establish audit program for Legend sponsored clinical trials

4. Conducts audits of clinical trial sites, suppliers, protocols, and study reports and reports all audit observations to clinical sites and Legend management

5. Conducts system and process audits as required, e.g. Pharmacovigilance, data management, and safety

6. Drive a continuous improvement / on-going development mind-set together with clinical operations team and management

7. Manage Quality metrics and key process indicators reporting through monthly quality reporting

8. Execute quality compliance activities: SOP approval, deviation documentation and CAPA

9. Establish and execute GCP training programs

10.Host local regulatory and health authority inspections

Qualifications:

1. Minimum of a Bachelor of Science degree in Medicine, Pharmacy, Biology or Nursing from an accredited college or university

2.  A minimum of 3-5 years of pharmaceutical company clinical development experience with at least 1 years’ GCP auditing experience in clinical research

3.  Experience and active participation in health authority inspections as well as performing clinical site, readiness inspections

4.  Working knowledge of Pharmacovigilance systems and processes is highly preferred

5.  Extensive knowledge of cGCP QA and compliance programs

6.   Extensive knowledge of ICH E6 and associated CFDA, FDA and EU GCP regulations is a must

金斯瑞生物科技股份有限公司（股票代码HK01548）是全球化的生物科技集团公司。集团植根于领先的基因合成技术，核心业务范围已涵盖生物药开发与生产CDMO业务、细胞与基因治疗、生命科学服务及产品、生物酶及合成生物学产品四大领域。

金斯瑞成立于2002年，并于2015年在港交所主板挂牌上市。集团总部位于中国南京，运营实体遍布大中华区、北美区、欧洲区及亚太区，并以此为依托，为全球160多个国家和地区的10多万客户提供优质、便捷、可靠的服务与产品。

目前，金斯瑞在全球拥有超过3000名员工，其中34%以上的员工拥有硕士或博士学位。金斯瑞拥有多项知识产权及技术机密，其中包含100多项授权专利及270多项专利申请。截至2019年6月30日，有超过40,300篇经国际同业审阅的学术期刊文献引述了金斯瑞的服务及产品。

秉承“用生物技术使人和自然更健康”的企业使命，金斯瑞将一如既往地致力于成为最受信赖的生物科技公司。