Senior Auditor, Audits and Inspections Program - US/Canada - Remote

Broad expertise related to understanding the principles and application of quality and regulatory compliance related to GxP activities. Excellent working knowledge of ICH Guidelines, FDA regulations, European Directives, MHRA Statutory Instruments, and AIFA CRO Decree. Broad experience related to understanding the principles and application of quality and regulatory compliance related to GxP activities, specifically GCP. Excellent experience in conducting QA Audits, specifically GCP for each type (i.e. Clinical Investigator Audits, Vendor Audits, Internal Process Audits, For-cause Audits, Document Audits, etc.). Previous experience in trending and analysis methodologies. M.S. in a scientific or allied health filed and 5+ years of relevant GCP, GcLP, GLP, GVP, and / or GPP experience. Excellent understanding of the Drug Development Process. Minimum 3 years of Quality Assurance auditing experience. IT literate, experienced with Microsoft based applications, including proficiency in Excel, Word, Trackwise, SharePoint, and PowerPoint. Occasional domestic traveling required.

Champions and adheres to Worldwide’s Quality Management System (QMS). Serves as a positive ambassador of the QA organization with internal and external customers. Develops and executes personal and QA goals and objectives. Hosts external audits and regulatory inspections. Ensures quality deliverables, on time, and in compliance with regulations and Worldwide processes. Oversees, monitors and reports on QA audits to ensure timely completion of applicable CAPAs. Oversees the maintenance and archiving of records for each audit. Participates in driving continuous process improvements. Assists in developing training material and/or delivers training related to audits and inspections. Serves as a Subject Matter Expert on QA Quality Management processes for audits. Communicates relevant regulatory intelligence that has impact on the QMS to the QA team.