Job Description
- 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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