岗位职责：
1、Develops, maintains, and oversees the GxP quality system and associated strategy, processes, tools, and technologies for Mitro China, US and UK .
2、Develop and lead the audit process, including site audit, vendor audit etc..
3、Leads GxP audit response management and audit/inspection CAPAs to ensure suitability. Ability to lead GCP inspection readiness activities and support global health authority inspections.
4、Represent QA in issue escalation meetings. Risk assessment and remediation activities, major GCP issue investigation, trend analysis, CAPA and validity check in conjunction with local / global stakeholders/Customers.
5、Collaborates with clinical team to identify training needs for China, US, UK. Plans and provides training to clinical team. Review and update training curriculum in the Learning Management System.
6、Support the clinical team to develop clinical related procedure docs.

任职要求：
1、At least 5 years with MNC pharmaceutical R&D or global CRO quality related experiences.
2、Strong knowledge of GCP and ICH E6 R2.
3、Broad knowledge of global and Chinese regulatory requirements related to clinical studies.
4、GxP audit and inspection readiness experiences are required.
5、QMS establishment and implementation experiences are preferrable.
6、Bachelors or equivalent degree, health related (e.g., Medical, Scientific, Nursing, Pharmacy) preferred
7、Proficient in verbal and written English.