Regulatory Risk & Quality Manager

CICONIX, LLC•Fort Detrick, MD

2d•Onsite

About The Position

CICONIX LLC is a Veteran Owned Small Business specializing in business advisory and technical assistance for military health programs. We value exceptional people, unwavering integrity, inclusive collaboration, and enduring impact. 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. This role involves providing Knowledge Management and Regulatory Risk and Quality Management support for medical product development within the ORA. The manager will leverage expertise in applicable laws, regulations, and industry best practices to assist the ORA to mitigate regulatory risk and maintain product quality and safety. The position ensures compliance with all relevant national and international regulations and standards. It also provides 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. The primary objective is to maintain a fully compliant and audit-ready training program that safeguards participant safety and ensures data integrity.

Requirements

TBD
U.S. Citizenship and a successful background investigation are required.
Ability to obtain and maintain a government security clearance.
Willingness to comply with the government vaccination requirements.

Responsibilities

Developing and implementing knowledge management strategies to improve information flow and collaboration within the organization.
Identifying and mapping critical knowledge within the organization to ensure its preservation and accessibility.
Facilitating communities of practice to encourage knowledge sharing and peer-to-peer learning.
Implementing and managing knowledge management systems and tools, such as knowledge bases and enterprise search platforms, to centralize and make information easily discoverable.
Promoting a culture of knowledge sharing and continuous learning among employees.
Ensuring data accuracy and reliability within the knowledge systems.
Analyzing knowledge usage and effectiveness to identify areas for improvement and demonstrate the value of knowledge management initiatives.
Ensuring regulatory compliance for all medical products (drugs, biologics, and devices), with applicable guidance and regulations.
Ensuring Quality Management Systems are developed, implemented and managed in accordance with relevant standards, such as FDA 21 CFR 820, ISO 13485:2016, and Good Manufacturing Practices.
Documentation and Submission preparations, submission and maintenance to include SOPs development and management within ORA.
Leading audits and Inspections for internal and external customers, and regulatory audits (e.g., FDA audits).
Developing and reviewing CAPAs; Investigating non-conformances, customer complaints, and other quality issues to determine the root cause and implementing CAPAs.
Facilitating and documenting risk management activities in accordance with ORA SOPs, ISO 14971, including risk analysis, evaluation, and control for new and existing medical products.
Process risk management to include identifying and mitigating risks associated with manufacturing processes and quality systems.
Maintain a comprehensive training matrix for all research staff, detailing required courses, renewal dates, and role-specific educational needs.
Continuously monitor and track the training compliance of all personnel (including Principal Investigators, Sub-investigators, and Clinical Research Coordinators) engaged in clinical research.
Maintain accurate, complete, and up-to-date training records for all research personnel, ensuring they are readily available for internal audits, sponsor monitoring visits, and regulatory inspections.
Generate and distribute regular compliance reports.
Promptly notify relevant parties of any lapses in required training and oversee remediation.
Coordinate and document the initial training for all new staff members.
Periodically assess the effectiveness of the training program and recommend improvements or additional training modules as needed to address emerging 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 as per applicable regulations, standards, and FDA guidance.
Provide subject matter expertise and support for the development and implementation of in-house quality systems and procedures, to include the development/writing of new SOPs to support ORA compliance.
Survey personnel, review procedures, assess facilities, and write SOPs for entities conducting or assisting with non-clinical studies, clinical studies, or manufacturing test articles (Deliverable 60).
Upon request and per ORA SOPs provide quality control of deliverables by reviewing work products associated with deliverables in this contract.
Provide protocol, project, and procedure specific training to ORA and GDIT staff as well as personnel at clinical sites, CROs, CMOs, and other supported entities, to ensure that work is completed in an acceptable manner.
Plan and conduct audits for compliance with applicable regulations for the development and research of FDA regulated medical products to include preparing written audit plans and report(s).
Prepare clinical quality assurance management plans in accordance with Federal Code, guidance documents, including 21 CFR Part 312, 21 CFR Part 812, ICH Good Clinical Practice E6, and ISO 14155, and either Government SOPs or Contractor SOPs that have been reviewed and approved by the Government.