Quality Assurance Manager
2 weeks ago
Kelly Government Solutions is seeking an experienced individual to work as a Quality Assurance Manager (Clinical Research) at the National Institutes of Health in Rockville, MD. Position is estimated to support a hybrid work arrangement including remote and on-site work at the NIH in Rockville, MD.
TASKS
(1) Provide quality management support for NIAID Division of Microbiology and Infectious Diseases (DMID) clinical research activities.
(2) Support the development, implementation, maintenance, and oversite of a clinical quality management system at NIAID including document management, issue management, CAPA development, and quality assurance (QA) activities.
(3) Advance the writing of documents as part of the quality management system (SOPs, policies, audit reports, etc.), by both actively leading the development of documents and facilitating working groups to collaborate and write documents.
(4) Support the development and implementation of the Division’s electronic Quality Management System (eQMS).
(5) Stay current with changes to current industry standards and applicable regulations for quality in clinical research.
(6) Lead the oversight and management of quality assurance including investigator site audits, internal audits, and clinical vendors/CROs audits with guidance from management. This includes the development and/or review of tools including audit agendas, audit plans, audit reports, and CAPAs for internal and external audits.
(7) Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events.
(8) Assist in resolving compliance issues at clinical sites, clinical vendors, and contracted research facilities, provide assessment of the impact of any deficiencies, and identify ways to standardized processes to improve quality and/or facilitate efficiency
(9) Review, track and/or trend routine quality data; coordinate the development of QA-related metric reports.
(10) Report adverse trends to management with proposed remediation plan.
REQUIREMENTS
(1) Bachelor’s degree in a related discipline.
(2) Minimum of five (5) years of experience in clinical research including work at a research site and/or government agency
(3) Experience establishing and managing quality management systems for clinical research for IND sponsors (e.g., in pharmaceutical companies, biotechnology companies, or government sponsors).
(4) Working knowledge of the quality management cycle and corrective Action/Prevention Action (CAPA) processes; knowledge of electronic clinical quality management systems such as Master Control preferred
(5) Experience with US and international Good Clinical Practice (GCP), guidance documents, and industry best practice in all areas of a GxP environment.
(6) Experience conducting or overseeing audits and/or regulatory inspections from the US FDA or similar government regulatory authorities preferred.
(7) Ability to effectively build and maintain relationships with multiple departments and external entities (e.g., Investigator sites, clinical Vendors/CROs) to effectively troubleshoot and solve problems
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