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Job Title: Regulatory Affairs and Quality Manager
Job Number:
Organization: George Washington University
Posted: 1/29/2019
Type: Full-Time
Classification: Public Health - General
Industry: Academic Institutions
Number of Openings: 1
Location: Washington, DC,  DC   
Compensation:
Position Description: This position will support the Clinical Research Group (CRG) within the SMHS Departments of Medicine and Microbiology, Immunology & Tropical Medicine in the implementation and maintenance of the group’s clinical and laboratory quality management systems. Performs a variety of Quality Assurance activities that ensure compliance with FDA, ICH and GxP guidelines and regulatory requirements.

• Manages the day-to-day quality operations via oversight of all elements of the CRG’s Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, batch review and disposition, data integrity, and training • Manage all aspects of group’s training system including maintenance of training records, oversight of training compliance, and periodic auditing of training records. • Collaborate to identify quality issue root cause and track CAPA investigations; work with clinic and/or lab staff to bring investigations to completion • Provide direct operational support for internal/external GxP audits, and support regulatory inspections, as needed • Prepare Standard Operating Procedures for existing and or developing programs/facilities • Serve as the Quality Manager for lot release of Necator americanus hookworm larvae for use in clinical trials, performing review of manufacturing records and quality control data. • In coordination with other operational groups (e.g., MITM Clinical Immunology Lab, MITM Parasitology Lab, GW MFA), support initiatives that contribute to a continual state of inspection readiness for clinical trial programs • Contribute to FDA regulatory submissions, annual reports, and clinical study reports

Qualifications: Bachelor's degree and 5 years of relevant professional experience. Knowledge of GCP, FDA, and other applicable regulations governing the conduct of clinical trials. Ideal candidate will have broad experience in basic clinical and/or laboratory operations, compliance principles in GCP, GLP and/or GMP, strong attention to detail and solid organizational skills.

Organization Description: The Clinical Research Group is part of the Research Center for Neglected Diseases of Poverty, located at the George Washington University School of Medicine and Health Sciences. This position will support the Clinical Research Group (CRG) within the SMHS Departments of Medicine and Microbiology, Immunology & Tropical Medicine in the implementation and maintenance of the group’s clinical and laboratory quality management systems.

Closing Date: 4/29/2019
Desired Starting Date:
Contact Name: David Diemert,  Regulatory Affairs and Quality Manager
Contact Location: 2300 Eye Street NW
524
Washington   DC  20037
United States
Contact Location: 2300 Eye Street NW
  524
  Washington   DC  20037
  United States
Contact Phone:  
Contact Fax:
Contact Email: ddiemert@gwu.edu
Web Address:
How to Apply: Applications must be submitted online at https://www.gwu.jobs/, search for posting #R000716 (title on the website is "Center Administrator/Quality Assurance).

Additional Information:

Web Site Delete Date: 4/29/2019