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
Manager • Indianapolis, Indiana, United States