Quality and Regulatory Compliance Specialist

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Updated: September 7, 2017
Job ID: 212589
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

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HJF is seeking a detail-oriented Quality and Regulatory Compliance Specialist to support our program, The Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO) located in Bethesda (Rockledge), Maryland. HJF provides scientific, technical and programmatic support services to ACESO.

The Quality and Regulatory Compliance Specialist will keep track of an ongoing clinical trials system validation process and maintain related documentation for compliance with FDA 21 CFR Part 11 regulations and standards. The Specialist will work closely with the system validation vendor during the validation process through completion, at which time the vendor will no longer provide validation services and the Specialist will solely maintain all related documentation for implementation of a QA compliance strategy to ensure FDA 21 CFR Part 11 compliance for the conduct of international FDA-regulated Investigational New Drug (IND) clinical studies. The Specialist will maintain the validation process methodology to implement and document repeatable and sustainable procedures to ensure ongoing compliance with FDA 21 CFR Part 11 regulations and standards. He or she will be responsible for maintaining QA/QC processes within the RedCap data management software as well as processes related to overall system validation.

The Specialist will work closely with the Joint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC) program which focuses on implementing a clinical research response capable of conducting FDA regulated clinical trials of therapeutics or diagnostics during an outbreak event. The position will be based at HJF headquarters in Bethesda, Maryland, with required travel 1-2 times/year to the JMEDICC site in Western Uganda.

This position reports to the ACESO Clinical Research Data Manager.


  1. Work closely with vendor throughout the validation process and help to create a master validation plan.
  2. Maintain methodology, processes and documentation for the validation plan compliant with 21 CFR Part 11.
  3. Support the maintenance of Risk Management and Control Plans.
  4. Ensure that the Site Validation Plan remains current and in compliance with US regulations, procedures and environmental, health and safety requirements
  5. Maintain and update validation protocols in line with master validation plan, regulations, procedures and practices. Review IQ, OQ, PQ and verification/validation documents in collaboration with cross-functional teams
  6. Maintain and update QC-related Standard Operating Procedures (SOPs), working practices, etc.
  7. Collaborate with project team members to ensure that the designs, procedures and outcome of the project are in good quality
  8. Interact directly with principle investigators, investigators, clinical research coordinators and other protocol team members to develop and document JMEDICC/ACESO processes to comply with FDA regulations
  9. Travel 1-2 times/year to international sites to document and monitor protocol, data management and QA procedures, and to train study staff on proper processes, regulations compliance and Site Validation Plan
  10. Ensure ISO and/or FDA compliance, direct and perform internal activities including review of related method validation audits, sponsor audits, development of quality system documents, and progress of studies, maintaining a master schedule and overseeing the relevant components of master validation plan
  11. Participate in quality system audits by regulatory agencies
  12. Prepare documentation for auditor examination, coordinating resources, respond to audit findings, and manage remediation efforts to closure
  13. Perform other duties as required

Required Knowledge, Skills, and Abilities:

  • Experience with REDCap data management software preferred
  • Experience with electronic Case Report Forms (eCRFs), electronic data collection
  • Experience with systems validation for FDA-regulated clinical trials
  • In-depth knowledge of FDA guidelines relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation
  • 3+ years experience (Master’s) or 5+ years (Bachelors) in healthcare industry or related government projects with exhibited knowledge or proficiency of industry standards for computer system validation.
  • Familiarity in a PV, GCP\Safety environment is highly desirable
  • Familiarity with 21CFR Part11 and other relevant assessments
  • Ability to interface with different groups and partners within the program
  • Ability to establish clear priorities quickly
  • Ability to work effectively independently, under pressure, handle multiple projects and meet deadlines
  • Strong verbal and written communication skills, good decision making skills and time management skills
  • Ability to travel as required to Western Uganda or other international site 1-2 times per year.

Minimum Education/Training Requirements:  Bachelor’s Degree in scientific, engineering, clinical or regulatory fields of study and 5+ years of experience OR Master’s Degree and 3+ years of experience in healthcare industry or related government projects with exhibited knowledge/proficiency in industry standards for computer and clinical trials IND study system validation.

Supervisory Responsibilities/Controls:  None

Work Environment:  Office with 10-15% international travel

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources.

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or other status protected by law.