Inspection Readiness Manager

Job Summary

Managing the execution of high-quality GCP & IVDR Inspection Readiness and Preparation, the full-time remote Inspection Readiness Manager will oversee project management for clinical trials, drive continuous improvement initiatives, and collaborate with cross-functional teams to ensure successful regulatory inspections.

Key responsibilities

• Lead GCP & IVDR Regulatory Site Inspection Readiness and Preparation project management, ensuring smooth inspection experiences
• Identify and act on quality incidents and trends to innovate operational quality inspection readiness
• Collaborate with the IR Support Team on function-specific GCP & IVDR initiatives and provide mentorship to interns

Required qualifications

• Bachelor's Degree in Life Sciences or RN or equivalent
• 7 years of work experience in life sciences or a medically related field, with 6 years in biopharmaceutical clinical research
• Experience overseeing global clinical trial conduct
• Proven track record in driving process development and improvement
• Preferred experience as an Inspection or Risk Manager