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

What you will do • 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 to personal and QA goals and objectives. • Performs QA audits for Vendors, Internal Process, Clinical Investigator, Document (Clinical Study reports, Trial Master File, Database) and other audits, as assigned. • 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 to prevent reoccurrence and to drive process improvements. • Oversees the maintenance and archiving of records for each audit. • Participates in the driving continuous process improvement. • Participates in the development and review of AIP Quality Management Documents, as assigned. • Provides support to Sponsors Audits and Inspections in relation to Worldwide provided services. • 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. • What you will bring to the role • Possesses 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. • Possesses 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. Your experience • 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. • Domestic and international travel required. We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.