FDA BIMO Inspections and Compliance Consultant

• 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.

• 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 supporting modernization activities
• Compensation: Competitive senior SME rate based on experience

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