Senior GMP Auditor

This is a 1099 Contract opportunity with no benefits. The job is a remote role with occasional travel to clients' sites across the US. The Senior GMP Auditor will perform a comprehensive, independent audit of a CDMO manufacturing and clinical packaging facility located in the US.

Requirements

• Minimum of fifteen years of GMP experience in pharmaceutical manufacturing, clinical packaging, or quality assurance, with significant time spent in auditing roles.
• Demonstrated experience conducting comprehensive audits of manufacturing and clinical packaging operations at CDMO or large pharmaceutical sites.
• Strong working knowledge of United States FDA regulations, ICH guidelines, and current industry expectations for clinical trial material manufacturing and packaging.
• Ability to travel to and work on site at the CDMO facility in the United States.
• Strong professional presence, objectivity, and sound judgment when interacting with site leadership and functional teams.

Benefits

• None