Associate Director, Quality Affairs

Join the HJF Team!

HJF is seeking an Associate Director, Quality Affairs to establish a Program-wide quality management system that promotes customer satisfaction and that positively impacts performance. The incumbent will manage all quality related activities such as vendor qualification program, regulated activities training records of employees involved in GMP/GCP activities, controlled document files including label archiving, and change control system for all actions critical to regulated activities.

This position will be in support of Quality Assurance/Diagnostics and Countermeasures Branch (DCB). The incumbent is responsible for the design and implementation of the Quality Assurance Program within the Diagnostics and Countermeasures Branch (DCB), Center for Infectious Disease Research (CIDR), Walter Reed Army Institute of Research (WRAIR). DCB encompasses two College of American Pathologists accredited laboratories, the HIV Diagnostics and Reference Laboratory (HDRL) and the Leishmania Diagnostics Laboratory (LDL), and two clinical research laboratories: the Research Assessment and Development (RAD) laboratory, and the Specimen Processing Laboratory and BioRepository (SPL/BioR). He/she will oversee DCB's QA Manager and the Quality team to ensure DCB laboratories are maintained at the highest U.S. regulatory agency and accrediting body standards to include the College of American Pathologists (CAP), Department of Defense (DoD) Clinical Laboratory Improvement Program (CLIP), Good Clinical Laboratory Practices (GCLP) for conduct of clinical trial research, and U.S. FDA requirements for conduct of testing and management of documentation supporting U.S. FDA regulated Pre-Market Application and 510K clinical trials.

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

• Oversees the development, implementation and revision of the Branch's Quality Management Program, ensuring timely creation and maintenance of all supporting documentation. Establishes and implements metrics for monitoring program effectiveness.
• Develops and executes an annual Quality Assurance Strategic Plan ensuring alignment with Branch goals, addressing areas that need updating based on new regulatory requirements, to include providing a comprehensive training program; implementing quality improvement projects and quality best practices as required.
• Serves as the primary quality Subject Matter Expert (SME). Reports to DCB Leadership on quality issues, trends and provides recommendations for quality improvement across DCB laboratories.
• Leads and manages, multiple quality, process improvement projects or high-priority projects, which often require considerable resources, regulatory knowledge and high levels of functional integration or assessment.
• Oversees internal quality audits and ensures the readiness of DCB laboratories for upcoming external/regulatory inspections. Oversees and monitors compliance and/or quality in accordance with professional standards, state and federal regulatory requirements, and accreditations.
• Practices and promotes innovative quality best practices within DCB using established policies, procedures or creates new procedures when needed.
• Tracks, trends overall key indicators of quality for all DCB laboratories to address areas that require improvement; developing action plans in collaboration with the Quality Group, DCB Leadership and Operations as required.
• Mentors and trains junior staff in the Quality Group as required for quality best practices and quality improvement.
• Participates in DCB meetings to include, but not limited to QA Leadership, Safety or Science.
• May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Supervisory Responsibilities

• Direct Supervisor: The incumbent will report directly to the Chief of Operations. The QA Manager, Quality Analyst, Technical Writer and Project Manager - Training and Development will report to the incumbent.. Direct authority to make decisions on the following: employee hiring, disciplinary action, starting salaries and merit increases; conduct employee performance evaluations and directs work activities.

Education and Experience

• Master's Degree is required, preferably in Molecular Biology, Virology, and or/Immunology.
• Minimum of 6-8 years of experience required.

Required Knowledge, Skills and Abilities

• Extensive experience in quality systems implementation and management with over 5 years of experience overseeing a quality group and establishing quality best practices in a regulated clinical laboratory environment.
• Strong interpersonal skills with the ability to deal effectively with a variety of personnel, consultants, contractors, etc. Experience implementing and using software systems to assist in managing quality programs and document control systems including deviations, CAPAs, investigations, etc.
• Knowledge of CLSI, GCLP, CAP/CLIA, DoD, CDC, OSHA and FDA requirements and experience implementing these requirements.
• Strong analytical, organizational, communication skills and excellent problem-solving skills are required.
• Ability to obtain and maintain a T1/Public Trust background check.

Physical Capabilities

• Lifting: Requires lifting materials up to 25 lbs.
• Ability to stand or sit at a computer for prolonged periods.

Work Environment

• This position will take place primarily in an office setting.

Compensation

• The annual salary range for this position is $100,500-$147,890. Actual salary will be determined based on experience, education, etc.

Benefits

• HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35

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