Quality Manager (SME)

Join the HJF Team!

HJF is seeking an Quality Manager (SME) to 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. Contractor will serve as the subject matter expert in required areas of expertise and provide industry best practice solutions to extremely complex problems being addressed. The contractor shall have the ability to analyze these extremely complex problems and recommend, monitor and execute best practice solutions to executive level management

This position will be in support of United States Army Medical Research Institute of Infectious Diseases (USAMRIID) Technical Research Support Services located at Fort Detrick in Frederick, MD. USAMRIID works closely with other U.S. Army Medical Research and Development Command (USAMRDC) organizations, Department of Defense (DoD), the Interagency (including Interagency Laboratories), and private companies to accomplish its mission of protecting the Warfighter from biological threats and being prepared to investigate disease outbreaks or threats to public health. This includes conducting Research, Development, Testing, & Evaluation (RDTE) of medical countermeasure against biological threats and the safety, quality assurance, project management, and core support required for these research activities.

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.

• Contractor shall maintain all documentation necessary for ISO 17034, ISO 17025, and CLIP functional accreditation. Maintain ISO 17034, ISO 17025, and CLIP accreditation on a yearly basis.
• Contractor shall perform quality systems audits in support of accreditation and GLP studies. Workload is typically 12 audits per year encompassing all aspects of ISO 17034, ISO 17025, and CLIP accreditation.
• Contractor shall organize and support external inspections and quality systems management inquiries in support of Divisional accreditation. Workload is 3 inspections/accreditation filings per year. Provide a monthly report on Quality Management Inspection status.
• Contractor shall interact with external Divisional personnel for all support activities (i.e., equipment, facilities, and audits) involved in the maintenance of the Divisional Quality Management System (QMS). Interactions shall occur at least monthly.
• Contractor shall develop and implement programs to maintain and improve upon the quality and performance of the laboratory. This includes ensuring that the laboratory retains its accreditation as a reference material producer and clinical diagnostic facility. Quality improvement programs shall be developed annually, and results reported annually. Quality Improvement Program updates shall be provided quarterly.
• Contractor shall execute oversight and continuing improvement of the Division's established equipment qualification and software validation program, QMS processes, and procedures. Workload is typically 1 validation per quarter.
• Contractor shall attend Assessment Accreditation Services (A2LA) or similar laboratory accreditation program training to supplement existing quality improvement programs as required. CONUS travel may be required.
  Performs complex analysis of situations or data that require an in-depth evaluation such as out of specification incidents.
• Serves as the primary quality resource for problem identification, risk assessment, resolution, and loss. Reports to management on quality issues, trends and losses.
• Initiates and implements quality improvement activities as appropriate to raise the performance of the program. Designs, implements and documents procedures for process control and improvement. Champions continuous improvement efforts to establish an effective Quality Management System (QMS). Develops quality planning methods for all processes. Establishes and implements metrics for monitoring system effectiveness to enable managers to make sound quality decisions.
• Educates and train employees as to their impact in the quality management system. Interfaces with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.

Supervisory Responsibilities

• Direct Supervisor: 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

• Minimum Master's Degree in scientific discipline.
• Minimum of 10 years of experience required.

Required Knowledge, Skills and Abilities

• Possess the technical capability for oversight of issues related to the maintenance of the Divisional Quality Management System (QMS)
• Experience in quality systems implementation and management
• Strong working knowledge of ISO 17034, ISO 17025, and CLIP functional accreditation.
• Strong interpersonal skills with the ability to deal effectively with a variety of personnel, consultants, contractors, etc.
• Contractor shall obtain and maintain eligibility for an active SECRET security clearance.

Physical Capabilities

• Lifting: Requires lifting materials up to 10 lbs.
• Ability to stand or sit at a computer for prolonged periods.

Work Environment

• This position will take place primarily in an office and/or clinic setting.

Compensation

• The annual salary range for this position is $100,500 - $186,600. Actual salary/hourly pay 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(c)

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