FDA BIMO Inspections and Compliance Consultant

Fda Bimo Inspections And Compliance Consultant Medvacon Life Sciences is seeking a highly experienced FDA BIMO Inspections and Compliance Consultant to serve as a subject matter expert supporting FDA's modernization and consolidation of BIMO inspection and compliance systems. This role provides deep domain expertise in FDA inspection processes, regulatory requirements, and BIMO program operations, working closely with FDA stakeholders, IT teams, data architects, business analysts, and program leadership. The consultant will ensure that system workflows, data rules, analytics, and inspection support tools accurately reflect real world BIMO inspection practices and federal regulatory expectations. Key Responsibilities BIMO Program Subject Matter Expertise Serve as the primary SME for FDA BIMO inspection processes, requirements, and operational workflows. Interpret and apply 21 CFR Parts 11, 50, 54, 56, 312, 812 and ICH E6 to system, process, and data design. Advise on inspection practices across investigator sites, IRBs, sponsors, CROs, nonclinical labs, and analytical facilities. Support for Workflow, System, and Tool Design Collaborate with FDA program teams, IT developers, and analysts to define BIMO inspection workflows and functional requirements. Validate user stories, acceptance criteria, and screen designs to ensure alignment with BIMO processes. Provide input during sprint reviews, design sessions, and requirements workshops. Risk-Based Site Selection and Inspection Support Advise on design and refinement of risk-based site selection logic and related analytics. Review risk factors, scoring models, and data inputs to ensure they reflect real inspection priorities. Support development of inspection support tools, document workflows, and decision-support features. Data and Analytics Expertise Define key BIMO data elements needed for workflow, reporting, analytics, and decision-making. Collaborate with data architects on data mapping, data quality rules, and integration requirements. Review dashboards, visualizations, and analytic outputs for accuracy and regulatory alignment. Documentation, Testing, and Training Support documentation of BIMO processes, requirements, and system behavior. Participate in user acceptance testing to validate that system behavior aligns with BIMO business rules. Assist in developing training content for new tools, workflows, dashboards, and reporting features. Cross-Functional Collaboration Participate in meetings, sprint reviews, planning sessions, and workshops with program leadership and technical teams. Provide clear regulatory and process guidance to ensure BIMO compliance is correctly embedded into design. Required Qualifications Bachelor's degree in Life Sciences, Nursing, Pharmacy, 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 483s, Warning Letters, or major audit findings. Demonstrated ability to translate regulatory and inspection requirements into structured workflows, rules, or requirements. Excellent communication skills, including documentation, requirements explanation, and training. Preferred Qualifications Experience collaborating with IT, data, analytics, or system development teams. Familiarity with inspection support systems, workflow tools, data hubs, or analytics platforms. Experience with risk-based site selection methodologies. Professional certifications such as ASQ CQA, RQA, or SQA. Key Attributes Strong analytical and structured thinking skills. Ability to bridge regulatory expertise with technical system design. Comfortable working with multidisciplinary teams and providing clear SME direction. High attention to detail and strong regulatory judgment. Position Details Employment Type: 1099 Location: Maryland/Virginia Engagement Type: Project-based consulting supporting FDA modernization activities Compensation: Competitive senior SME rate based on experience

Created: 2026-03-04