Regulatory Risk & Quality Manager
CICONIX, LLC, Frederick, MD, United States
Regulatory Risk & Quality Manager
Regulatory Risk & Quality Manager position at CICONIX LLC, a Veteran Owned Small Business specializing in business advisory and technical assistance for military health programs. Location: Fort Detrick, MD.
Location
Fort Detrick, MD
Position Details
Full-time position
Regular weekly hours (09:00–16:00)
No calls, nights, weekends, or holidays
Full benefits program, including health, PTO, and 401k + employer contribution
Summary
CICONIX is seeking a Regulatory Risk & Quality Manager to support the Office of Regulated Activities (ORA) in support of the Defense Health Agency Research and Development Medical Research and Development Command (DHA R&D MRDC) team in Fort Detrick, MD.
Responsibilities
Provide Knowledge Management and Regulatory Risk and Quality Management support for medical product development within the ORA.
Leverage expertise in applicable laws, regulations, and industry best practices to mitigate regulatory risk and maintain product quality and safety.
Ensure compliance with all relevant national and international regulations and standards.
Provide expert support to ensure all personnel involved in the conduct of clinical human research are appropriately trained in accordance with institutional policies, sponsor requirements, and applicable federal regulations, including Good Clinical Practice.
Maintain a fully compliant and audit-ready training program that safeguards participant safety and ensures data integrity.
Develop and implement knowledge management strategies to improve information flow and collaboration.
Identify and map critical knowledge to ensure preservation and accessibility.
Facilitate communities of practice to encourage knowledge sharing and peer learning.
Implement and manage knowledge management systems and tools to centralize information and improve discoverability.
Promote a culture of knowledge sharing and continuous learning; ensure data accuracy and reliability within knowledge systems.
Analyze knowledge usage to identify areas for improvement and demonstrate value of knowledge management initiatives.
Ensure regulatory compliance for all medical products (drugs, biologics, devices) per applicable guidance and regulations.
Develop, implement, and manage Quality Management Systems IAW FDA 21 CFR 820, ISO 13485:2016, and Good Manufacturing Practices.
Prepare documentation and submissions, including SOP development and management within ORA.
Lead internal and external audits and inspections (e.g., FDA audits).
Develop and review CAPAs; investigate non-conformances and quality issues; determine root causes and implement CAPAs.
Facilitate and document risk management activities IAW ORA SOPs and ISO 14971, including risk analysis, evaluation, and control for new and existing medical products.
Manage process risk for manufacturing processes and quality systems.
Manage Training Program: maintain a comprehensive training matrix for all research staff, detailing required courses, renewal dates, and role-specific needs.
Monitor training compliance of personnel engaged in clinical research (Principal Investigators, Sub-investigators, Clinical Research Coordinators).
Maintain accurate training records for internal audits, sponsor monitoring visits, and regulatory inspections.
Generate and distribute regular compliance reports; notify relevant parties of training lapses and oversee remediation.
Coordinate onboarding and initial training for new staff members.
Periodically assess training effectiveness and recommend improvements to address compliance trends or corrective actions.
Perform independent reviews and provide reports on documentation, sites, organizations, and facilities to ensure compliance with quality requirements for medical product development and clinical studies per regulations and FDA guidance.
Provide subject matter expertise and support for in-house quality systems and procedures, including writing SOPs to support ORA compliance survey personnel and facilities assessments.
Provide quality control of deliverables by reviewing work products as requested by ORA SOPs.
Provide protocol, project, and procedure-specific training to ORA and GDIT staff, clinical sites, CROs, CMOs, and other supported entities.
Plan and conduct audits for regulatory compliance in FDA-regulated medical product development, including audit plans and reports.
Prepare clinical quality assurance management plans in accordance with applicable codes and guidance (e.g., 21 CFR Parts 312, 812; ICH GCP E6; ISO 14155) and government or contractor SOPs.
Qualifications
Education: TBD
Licensure & Certifications (Current & Unrestricted): TBD
Experience: TBD
Security & Background Check: U.S. Citizenship and ability to obtain/maintain government security clearance.
Additional Requirements: Willingness to comply with government vaccination requirements.
Compensation
TBD
This position is contingent and will begin upon contract award.
Equal Employment Opportunity
CICONIX LLC is an Equal Opportunity Employer, including disability/vets. We E-Verify all employees.
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Regulatory Risk & Quality Manager position at CICONIX LLC, a Veteran Owned Small Business specializing in business advisory and technical assistance for military health programs. Location: Fort Detrick, MD.
Location
Fort Detrick, MD
Position Details
Full-time position
Regular weekly hours (09:00–16:00)
No calls, nights, weekends, or holidays
Full benefits program, including health, PTO, and 401k + employer contribution
Summary
CICONIX is seeking a Regulatory Risk & Quality Manager to support the Office of Regulated Activities (ORA) in support of the Defense Health Agency Research and Development Medical Research and Development Command (DHA R&D MRDC) team in Fort Detrick, MD.
Responsibilities
Provide Knowledge Management and Regulatory Risk and Quality Management support for medical product development within the ORA.
Leverage expertise in applicable laws, regulations, and industry best practices to mitigate regulatory risk and maintain product quality and safety.
Ensure compliance with all relevant national and international regulations and standards.
Provide expert support to ensure all personnel involved in the conduct of clinical human research are appropriately trained in accordance with institutional policies, sponsor requirements, and applicable federal regulations, including Good Clinical Practice.
Maintain a fully compliant and audit-ready training program that safeguards participant safety and ensures data integrity.
Develop and implement knowledge management strategies to improve information flow and collaboration.
Identify and map critical knowledge to ensure preservation and accessibility.
Facilitate communities of practice to encourage knowledge sharing and peer learning.
Implement and manage knowledge management systems and tools to centralize information and improve discoverability.
Promote a culture of knowledge sharing and continuous learning; ensure data accuracy and reliability within knowledge systems.
Analyze knowledge usage to identify areas for improvement and demonstrate value of knowledge management initiatives.
Ensure regulatory compliance for all medical products (drugs, biologics, devices) per applicable guidance and regulations.
Develop, implement, and manage Quality Management Systems IAW FDA 21 CFR 820, ISO 13485:2016, and Good Manufacturing Practices.
Prepare documentation and submissions, including SOP development and management within ORA.
Lead internal and external audits and inspections (e.g., FDA audits).
Develop and review CAPAs; investigate non-conformances and quality issues; determine root causes and implement CAPAs.
Facilitate and document risk management activities IAW ORA SOPs and ISO 14971, including risk analysis, evaluation, and control for new and existing medical products.
Manage process risk for manufacturing processes and quality systems.
Manage Training Program: maintain a comprehensive training matrix for all research staff, detailing required courses, renewal dates, and role-specific needs.
Monitor training compliance of personnel engaged in clinical research (Principal Investigators, Sub-investigators, Clinical Research Coordinators).
Maintain accurate training records for internal audits, sponsor monitoring visits, and regulatory inspections.
Generate and distribute regular compliance reports; notify relevant parties of training lapses and oversee remediation.
Coordinate onboarding and initial training for new staff members.
Periodically assess training effectiveness and recommend improvements to address compliance trends or corrective actions.
Perform independent reviews and provide reports on documentation, sites, organizations, and facilities to ensure compliance with quality requirements for medical product development and clinical studies per regulations and FDA guidance.
Provide subject matter expertise and support for in-house quality systems and procedures, including writing SOPs to support ORA compliance survey personnel and facilities assessments.
Provide quality control of deliverables by reviewing work products as requested by ORA SOPs.
Provide protocol, project, and procedure-specific training to ORA and GDIT staff, clinical sites, CROs, CMOs, and other supported entities.
Plan and conduct audits for regulatory compliance in FDA-regulated medical product development, including audit plans and reports.
Prepare clinical quality assurance management plans in accordance with applicable codes and guidance (e.g., 21 CFR Parts 312, 812; ICH GCP E6; ISO 14155) and government or contractor SOPs.
Qualifications
Education: TBD
Licensure & Certifications (Current & Unrestricted): TBD
Experience: TBD
Security & Background Check: U.S. Citizenship and ability to obtain/maintain government security clearance.
Additional Requirements: Willingness to comply with government vaccination requirements.
Compensation
TBD
This position is contingent and will begin upon contract award.
Equal Employment Opportunity
CICONIX LLC is an Equal Opportunity Employer, including disability/vets. We E-Verify all employees.
#LI-AD1
#J-18808-Ljbffr