北京招聘

岗位职责：
1.Coordinate the establishment , implement and continuous improvement of clinical quality management systems.
2.Provide QA guidance to the establishment, implement and continuous improvement of clinical quality management systems (for director level and above).
3.Attend or prepares, conducts clinical quality system audits, generates audit reports, communicates results to Clinical QA Executive Director and relevant business stakeholders, and interacts with various teams to ensure corrective and preventative actions are taken to bring system observations to closure as applicable.
4.Activities may include GCP related routine and directed audits of system , vendors, regulatory documents.
5.Support Significant System Issues management for clinical quality management system, including assessment of potential root causes and remediation (corrective and preventative actions) as needed.
6.and audit tools to ensure cQA consistency internally ( for Director level).
7.Acts as a strong technical resource to resolve clinical quality management issues based on knowledge of relevant SOPs, GXP, applicable local regulations &guidelines.
8.Manage the creation, review, and revision of SOPs and training documentation.

任职要求：
1.Strong knowledge of any area of GCP or GLP or GVP or GMP, SOPs and quality system processes; broad knowledge of the drug development process.
2.Quality systems demonstrated working knowledge in areas such as document management, document change control audits.
3.Working knowledge of quality systems and regulatory requirements (knowledge on 21 CRF Part 11 is preferred )
4.BS/BA degree in relevant area with experience in clinical operation, project management field, GMP/GLP/GVP Quality Assurance and experience in the pharmaceutical industry including experience of audits is preferable.

创胜集团是一家临床阶段的在生物药发现、研发、工艺开发和生产方面具有全面综合能力的生物制药公司。2021年9月29日，创胜集团在香港联合交易所主板上市，股票代码：06628。

创胜集团总部位于苏州，已成功搭建了全球的业务布局：在苏州设有药物发现、临床和转化研究中心，在杭州拥有工艺与产品开发中心以及药物生产基地，在北京、上海、广州和美国普林斯顿分别设有临床开发中心，并在美国波士顿、洛杉矶设立了对外合作中心。创胜集团的开发管线已有九个治疗用抗体新药分子，涵盖肿瘤、骨科和肾病等领域。

迈博斯生物医药(苏州)有限公司是创胜集团医药有限公司的全资附属公司，由国家创业领军型人才钱雪明博士于2012年创立，专注于创新生物药发现、临床研究和商业化开发，重点关注癌症和其他疾病的抗体治疗领域。迈博斯生物在苏州生物医药产业园拥有占地5000平方米的药物发现、临床和转化研究中心，公司自主研发的免疫耐受屏障突破技术平台能发现具有更多表位的抗体，并根据此技术建立了多个抗体发现及共同开发的合作关系，以研发更多能拯救生命且经济有效的抗体疗法。