Associate Director, Quality Affairs and Program Compliance - IDCRP

Join the HJF Team!

HJF is seeking a Associate Director, Quality Affairs and Program Compliance as part of the Infectious Disease Clinical Research Program (IDCRP) Center Operations team and is responsible for oversight and management of key aspects of IDCRP compliance including quality management, regulatory compliance, training, records management, protocol QA, special projects, and personnel supervision. The incumbent will also provide expertise and guidance to IDCRP clinical research study teams for single and multicenter clinical study protocols, including FDA-regulated clinical trials. Supervised by the IDCRP Director, Center Operations.

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.

U.S. Citizenship required due to security requirements.

• Oversees and ensures capability, preparation, management, and reporting of protocol and clinical research operations quality assurance and regulatory compliance across the IDCRP, including standardization, documentation, and coordination of related activities.
• Coordinates with other IDCRP component heads (Clinical Research Operations, Data Operations, Lab/Repository Operations, Program Management), protocol teams, and others to ensure effective research support including integrated quality management and regulatory compliance.
• Supervises or oversees, training, and mentors' staff including in Quality Assurance, Regulatory Affairs, and other required program training.
• Provides expert guidance and input to Directors, Principal Investigators, component heads, and protocol teams regarding protocol design, quality management, and regulatory compliance. Provides templates, checklists, and other materials to ensure regulatory compliance. Reviews and approves protocol Quality Management Plans and receives and reviews resulting reports during protocol execution; takes appropriate actions as required.
• Oversees and tracks program records management lifecycle for both research (Florence) and administrative documents.
• Assigned to special projects and other duties.

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

• Master's Degree required.
• Minimum of 6-8 years of experience required.

Required Knowledge, Skills and Abilities

• Possess the technical capability for oversight of issues related to vaccine development, GMP manufacturing and testing, and clinical trials.
• Minimum of five years with clinical trials, such as experience working with IRBs, protocol development or clinical monitoring.
• Experience in quality systems implementation and management with five years as a QA Associate Director or Director in a medium-size pharmaceutical manufacturing and/or clinical environment.
• Strong working knowledge of cGMPs, cGLPs, and cGCPs as well as knowledge of international quality and regulatory requirements for parenteral manufacturing operations.
• 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 stability programs and document control systems including deviations, CAPAs, investigations, etc.
• Background in infectious diseases or related scientific field is required.
• U.S. Citizenship Required; Ability to obtain and maintain a T3 Secret Clearance.

Work Environment

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

Compensation

• The annual salary range for this position is $105,800-$155,000. 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(c)

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