Reporting to the President/CEO, the Director, and Quality Assurance is responsible for the planning, administration, and monitoring of consistent readiness of all quality management, regulatory compliance and quality improvement processes. He/she will guide the QA department to conduct quality assurance audits and surveillance; conduct quality assurance investigations of nonconforming products/processes and coordinate corrective actions according to NDRI’s Problem Management procedures. This position requires an experienced leader to manage the NDRI’s Global Quality program and support the organization’s commitment to the maintenance of NDRI’s Quality Systems.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Oversee quality assurance functions in accordance with the NDRI Quality Manual and NDRI’s mission.
Promote continual improvement, quality achievement, and performance improvement throughout NDRI projects and programs.
Supervise and administer the activities of the Quality Assurance staff to effectively achieve NDRI’s mission.
Ensure the integration of quality in operational processes and practices through the review and evaluation of practices within procedures, data base accuracy, hard copy donor records, and tissue source site compliance as required in the NDRI Quality Manual and Quality Policy.
Design, interpret, and implement Quality Assurance systems and practices in accordance with federal, state, and other regulations and requirements.
Experience with accreditation and quality requirements and regulations such as National Committee for Quality Assurance (NCQA), College of American Pathologists (CAP)
Monitor, report and make recommendations for improvement to NDRI Quality management trends, non-conformances/deviations via the Problem Management System, Quality System Reviews, operationally-related accidents/incidents (in coordination with HR), and customer complaints.
With Business Development, coordinate opportunities to ensure integration of implemented quality assurance practices.
Manage the employee training program as it applies to the Quality Management System (QMS); identify relevant training needs by implementing training programs to assure compliance with NDRI standard operating procedures.
Responsible for tissue source site qualification activities.
Responsible for the review of equipment validation, including guidance to ensure the validation activities meet the requirements of NDRI’s Quality Manual and Quality Policy.
Responsible for all Quality Assurance standards and final approval of NDRI policies and procedures.
Maintain current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring.
Master's degree is required with 7-10 years of quality program management experience.
Minimum 7-10 yrs. experience in Quality Systems Management Implementation, QA Administration, and QA Audit process and in a medical research-related environment.
Quality related certifications required: Certified Tissue Bank Specialist (AATB) and/or Certified Quality Auditor (ASQ)
Demonstrated competency in computer skills: MS office applications, query tools, and enterprise database systems
Additional Salary Information: PTO, Life Insurance, Retirement Plan, Health Insurance (Medical, Dental, Vision)
About NDRI - National Disease Research Interchange
NDRI, The National Disease Research Interchange, is a non-profit, funded by the National Institutes of Health, pharmaceutical companies, foundations and the general public, founded in 1980 to provide donated human pancreas tissues for diabetes research studies. The organization broadened its focus, by obtaining human tissue samples of all kinds sent to the nation’s best researchers in hopes of effecting advances and discoveries. NDRI works to help translational advances in almost every disease. By providing human cells, tissues and organs to researchers and scientists, NDRI works on the cutting edge of disease research. For more information, please visit www.ndriresource.org.