岗位职责：
•Provide quality oversight of the research laboratory to ensure laboratory operations, data integrity, and compliance are being addressed and managed appropriately.
•Serve as a QA representation at cross-functional meetings whereby GCLP/GLP/research activities are being discussed.
•Responsible for engaging directly with Health authorities to address compliance relevant matters and lead any remediation efforts.
•Support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for internal and external oversight.
•Manage and conduct the QA review of GLP/GCLP and research study protocols, clinical study reports, external publications, and regulatory authority submissions.
•Provide quality oversight of vendors that are responsible for biomarkers, special analytical methods, assays etc., are assessed and that any nonconformance is appropriately mitigated.
•Conduct end-to-end audit activities per audit program of nonclinical/GCLP relevant audit activities.
•Develop and manage metrics for reporting purposes at senior leadership meetings.
•Review, define, develop SOPs, instructions, manuals, inspection readiness strategy for GLP/ research unit for global activities.
•Ensure regulated activities related to computerized systems are in place and that all regulations being adhered to.
•Identify QA compliance issues pertinent to GLP/GCLP activities, implementing solutions and partnering with stakeholders to ensure a compliant ready state of operation.
•Collaborate with QMS team and applicable QA function to ensure no overdue CAPAs.
资历要求：