MEDVACON LIFE SCIENCES, LLC · 8 hours ago
FDA BIMO Inspections and Compliance Consultant
Washington, DC
Full-time
Hybrid
Senior Level
7+ years expMedvacon 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.
ConsultingHuman ResourcesLife ScienceQuality Assurance
Responsibilities
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
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
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
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
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
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
Qualification
Required
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
Preferred
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
Company
MEDVACON LIFE SCIENCES, LLC
MEDVACON is a globally recognized company offering tailored FDA Quality Compliance and Technical Consulting Services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Raymond Roggero
Managing Partner
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