MEDVACON LIFE SCIENCES, LLC
FDA BIMO Inspections and Compliance Consultant
MEDVACON LIFE SCIENCES, LLC, Baltimore, Maryland, United States, 21276
FDA BIMO Inspections and Compliance Consultant
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MEDVACON LIFE SCIENCES, LLC provided pay range This range is provided by MEDVACON LIFE SCIENCES, LLC. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $90.00/hr - $100.00/hr
Senior Talent Acquisition Specialist I Recruitment SME I Life Sciences I at MEDVACON Life Sciences, LLC This is a 1099 contract role with no benefits.
This is a hybrid role based in Washington, D.C.
Position Overview 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.
Location: Maryland / Virginia
Engagement Type: Project-based consulting supporting FDA modernization activities
Compensation: Competitive senior SME rate based on experience
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.
Seniority level Mid-Senior level
Employment type Full-time
Job function Consulting and Project Management
Industries Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
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MEDVACON LIFE SCIENCES, LLC provided pay range This range is provided by MEDVACON LIFE SCIENCES, LLC. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $90.00/hr - $100.00/hr
Senior Talent Acquisition Specialist I Recruitment SME I Life Sciences I at MEDVACON Life Sciences, LLC This is a 1099 contract role with no benefits.
This is a hybrid role based in Washington, D.C.
Position Overview 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.
Location: Maryland / Virginia
Engagement Type: Project-based consulting supporting FDA modernization activities
Compensation: Competitive senior SME rate based on experience
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.
Seniority level Mid-Senior level
Employment type Full-time
Job function Consulting and Project Management
Industries Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing
#J-18808-Ljbffr