FDA BIMO Inspections and Compliance Consultant

This is a 1099 contract role with no benefits. This is a hybrid role based in Washington, D.C.

Medvacon Life Sciences is seeking 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. The consultant will provide quality and regulatory expertise to ensure inspection workflows, documentation expectations, data integrity requirements, and reporting outputs accurately reflect real world BIMO inspection practice and federal regulatory expectations.

This is a quality and compliance SME role focused on inspection readiness and regulatory alignment. It is not a programming, software development, or IT engineering position.

• BIMO Program Subject Matter Expertise
  • Serve as the primary SME for FDA BIMO inspection processes, requirements, and operational workflows
  • Advise on inspection practices across clinical investigators, IRBs, sponsors, CROs, nonclinical laboratories, and analytical laboratories
  • Interpret and apply applicable regulations and guidance to inspection readiness practices, documentation expectations, and data integrity requirements

• Inspection Process And Requirements Validation
  • Review and validate inspection related workflows, process steps, decision points, and required documentation to ensure alignment with BIMO practice
  • Provide SME input on role responsibilities, inspection documentation needs, and inspection ready recordkeeping expectations
  • Review materials prepared by the delivery team, such as process descriptions and requirements write ups, to confirm they reflect inspection operations and compliance expectations
  • Participate in working sessions and reviews to answer BIMO process questions and resolve workflow edge cases

• Risk Based Prioritization Support
  • Review and validate risk based prioritization approaches used to support inspection planning and targeting
  • Confirm that proposed risk factors and prioritization logic reflect real inspection priorities and are defensible from a compliance standpoint
  • Provide feedback on how inspection teams use risk information and what documentation is needed to support inspection decisions

• Data Integrity and Reporting Validation
  • Define and validate key BIMO data elements needed for inspection activities, documentation, and oversight reporting
  • Review data definitions and data quality rules to ensure they support traceability, data integrity, and inspection readiness expectations
  • Review reporting and dashboard outputs for accuracy, completeness, and regulatory alignment, and confirm they are meaningful for inspection planning and oversight

• Documentation, Testing, and Training Support
  • Support documentation of BIMO processes, requirements, and expected outputs in clear, inspection ready language
  • Participate in user acceptance testing by validating that outputs and workflow behavior align with BIMO business rules and inspection expectations
  • Assist in developing training content and reference materials for end users, focused on compliant use and inspection ready practices

• Cross Functional Collaboration
  • Provide clear regulatory and process guidance to multidisciplinary teams to ensure BIMO compliance is correctly embedded into practices and outputs
  • Communicate inspection expectations clearly to both technical and non-technical audiences

• Bachelor’s 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
• In depth understanding of FDA inspection processes and BIMO program expectations
• 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
• Demonstrated ability to translate inspection and regulatory requirements into clear, structured inspection readiness processes, documentation standards, and validation criteria
• Excellent communication skills including documentation, requirements explanation, and training

• Experience supporting inspection readiness across multiple organizations or partners, including sponsors, CROs, investigator sites, IRBs, and laboratories
• Experience reviewing or validating inspection related processes, documentation frameworks, and oversight reporting outputs with cross functional teams
• Professional certifications such as ASQ CQA, RQA, SQA, or equivalent

• Strong analytical and structured thinking skills
• Strong regulatory judgment and attention to detail
• Ability to bridge compliance expectations with practical inspection readiness execution
• Comfortable working with multidisciplinary teams and providing clear SME direction

• Employment Type:
  
  1099
• Location:
  
  Maryland and Virginia
• Engagement Type:
  Project based consulting…