Inspection Readiness Manager

Job Summary

A company is looking for an Inspection Readiness Manager to oversee GCP & IVDR Inspection Readiness and Preparation for clinical trials.

Key Responsibilities

• Lead GCP & IVDR Regulatory Site Inspection Readiness and Preparation project management
• Innovate continuous improvement in operational quality inspection readiness
• Collaborate with the IR Support Team on GCP & IVDR initiatives and manage related documentation

Required Qualifications

• Doctorate degree OR Master's degree with 2 years of relevant experience OR Bachelor's degree with 4 years of relevant experience OR Associate's degree with 8 years of relevant experience OR High school diploma/GED with 10 years of relevant experience
• Bachelor's Degree in Life Sciences or equivalent preferred
• 7 years of work experience in life sciences or medically related field, including 6 years in biopharmaceutical clinical research
• Experience overseeing global clinical trial conduct
• Experience as an Inspection or Risk Manager preferred