Senior / Auditor, Audits And Inspections Program - Us/canada - Remote

Worldwide Clinical Trials

Remote
Fully remote
Gxp activities quality and regulatory compliance
Ich guidelines and fda regulations
Gcp auditing experience
Worldwide Clinical Trials is seeking a Senior Auditor for their Audits and Inspections Program, which is a remote position based in the US/Canada. The ideal candidate will have extensive experience in quality assurance within the clinical research environment, particularly with GCP, and will play a key role in maintaining high standards of quality and compliance

Job Summary

  • The Quality Assurance department sets the bar high when it comes to quality, committed to exceeding the quality standards required by sponsors, study participants, and regulatory authorities.
  • Performs QA audits for Vendors, Internal Process, Clinical Investigator, Document (Clinical Study reports, Trial Master File, Database) and other audits, as assigned, ensuring quality deliverables on time and in compliance with regulations.
  • Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, prioritizes attracting diverse talent and cultivating an inclusive environment.

Matching Summary

Match Score: 85

Worldwide Clinical Trials is seeking a Senior Auditor for their Audits and Inspections Program, which is a remote position based in the US/Canada. The ideal candidate will have extensive experience in quality assurance within the clinical research environment, particularly with GCP, and will play a key role in maintaining high standards of quality and compliance.

Skills & Requirements

Must-have

  • GxP activities quality and regulatory compliance
  • ICH Guidelines and FDA regulations
  • GCP auditing experience
  • Drug Development Process understanding
  • Microsoft Excel, Word, SharePoint, PowerPoint

Nice-to-have

  • Pioneering and creative approaches
  • Diverse and inclusive environment
  • Continuous process improvement
  • Subject Matter Expert on QA processes

Key Requirements

  • 5+ years of relevant GCP, GcLP, GLP, GVP, and / or GPP experience
  • Minimum 3 years of Quality Assurance auditing experience
  • M.S. in a scientific or allied health field
  • Domestic and international travel required

Work Rights

Not specified

Tailored Resume

Cover Letter