FDA BIMO Inspections and Compliance Consultant

This is a 1099 contract role with no benefits. The role is a hybrid position based in Washington, D.C. and requires a highly experienced FDA BIMO Inspections and Compliance Consultant to serve as a subject matter expert supporting modernization and consolidation of BIMO inspection and compliance practices.

Requirements

• Bachelors degree in Life Sciences, Nursing, Pharmacy, Public Health, or related field.
• Minimum seven years of experience in clinical research quality, GCP auditing, or regulatory compliance.
• Direct participation in at least two FDA BIMO or FDA GCP inspections within the last five years.
• Strong working knowledge of 21 CFR Parts 11, 50, 54, 56, 312, 812 and ICH E6.
• Experience developing CAPAs or responses to FDA 483 observations, Warning Letters, or major audit findings.
• Excellent communication skills including documentation, requirements explanation, and training.

Benefits

• None