Senior / Auditor, Audits and Inspections Program - US/Canada - Remote
What you will do
• Champions and adheres to Worldwide’s Quality Management System (QMS).Â
• Serves as a positive ambassador of the QA organization with internal and external customers.Â
• Develops and executes to personal and QA goals and objectives.Â
• Performs QA audits for Vendors, Internal Process, Clinical Investigator, Document (Clinical Study reports, Trial Master File, Database) and other audits, as assigned.Â
• 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.Â
• 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.Â
• 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.Â
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.Â
We love knowing that someone is going to have a better life because of the work we do.Â
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.
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Apply To this Job
• Champions and adheres to Worldwide’s Quality Management System (QMS).Â
• Serves as a positive ambassador of the QA organization with internal and external customers.Â
• Develops and executes to personal and QA goals and objectives.Â
• Performs QA audits for Vendors, Internal Process, Clinical Investigator, Document (Clinical Study reports, Trial Master File, Database) and other audits, as assigned.Â
• 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.Â
• 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.Â
• 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.Â
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.Â
We love knowing that someone is going to have a better life because of the work we do.Â
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.
Apply tot his job
Apply To this Job