MMS is hiring a
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, investigator site audits, and related tasks such as audit planning, reporting, and debrief presentations.

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
• Conduct relevant audit documents such as: audit plan, audit report and debrief presentations
• Perform 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