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

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Requirements:

• 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.

Responsibilities:

• 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