Reporting to the Head of Quality Assurance, this position will be responsible for providing quality oversight both internally and externally related to the quality management system, audits, deviations,
Auditing late-phase clinical trials.
* Experience in investigator site audits, review of study data, and Data management audits.
* Statistical data auditing experience.
Strong knowledge of GxP requirements & Quality System processes.
* Working knowledge of relevant FDA, & EU regulations & ICH standards/guidelines and experience in supporting successful regulatory inspections.