Remote GCP Auditing Consultant

Summary

This job is a project-based consulting opportunity at an award-winning CRO, MMS. The role requires 5+ years of experience in GCP auditing within the CRO, Pharma, or Biotech industry and a Bachelor's Degree in a scientific, medical, or clinical discipline. Responsibilities include conducting vendor qualification audits and investigator site audits, vendor oversight and monitoring, performing investigations of errors, risk assessments, hosting regulatory authorities during inspections, and having good communication skills.

Requirements

• Minimum 5 years of experience in GCP auditing role within the CRO, Pharma, or Biotech industry
• Bachelor’s Degree in a scientific, medical, or clinical discipline
• Travel may be required for onsite audits

Responsibilities

• Independently conduct vendor qualification audits and/or investigator site audits
• Vendor oversight and monitoring, as needed
• Experience with performing investigations of errors investigations and risk assessments
• Experience with hosting and interacting with regulatory authorities during an inspection

Preferred Qualifications

• Familiarity with current ISO 9001 and ISO 27001 standards preferred
• Proficient experience with 21 CFR Part 11, FDA, and GCP requirements