Director of Quality Assurance

National Blood Testing Cooperative (NBTC) is seeking an experienced Director of Quality Assurance to lead the Quality Management System supporting testing services for more than 20 blood centers at Stone Mountain, Georgia laboratory.

The Director of Quality Assurance is responsible for overseeing all quality management activities to ensure compliance with applicable FDA, CLIA, AABB, 21 CFR, OSHA, and other regulatory and accreditation requirements. This position provides strategic leadership for quality assurance, validation, auditing, document control, supplier qualification, occurrence management, CAPA, continuous process improvement, and inspection readiness.

Working closely with onsite laboratory leadership, the Director develops, implements, and maintains quality policies and programs; supports operational excellence; and promotes a culture of quality and regulatory compliance. The position partners with laboratory managers on performance improvement, employee development, and strategic initiatives to ensure the laboratory consistently delivers safe, accurate, reliable, and timely testing services.

This is an outstanding opportunity for a collaborative and strategic quality leader who is passionate about regulatory excellence, continuous improvement, and advancing the safety and reliability of the nation’s blood supply. 

What You Will Do:

• Interacts with appropriate department supervisors concerning quality assurance/quality control programs within their respective areas
• Maintain all quality assurance and procedures
• Maintain an internal assessment (audit) program to monitor compliance in all functions.
• Develop and report key point indicator data
• Facilitates communication between the Donor Testing Lab and external investigators and participants in external inspections. Approves all responses and corrective actions required.
• Reviews and ensures written approval of SOP’s prior to implementation and that SOP’s comply with all applicable regulatory requirements
• Assists in developing, reviewing and ensuring the approval of training and educational programs for personnel, to include factors that indicate a need for training or retaining
• Reviews quality control procedures, analyzing results for trends or patterns to identify specific problems
• Ensures that adequate validation procedures have been performed
• Provides assurance that procedures are in place and followed through a comprehensive error/accident, complaint and adverse reaction reporting systems
• Evaluates the facilities systems through audit procedures. Performs comprehensive audits to review a statistically significant number of records, or focused audits to monitor a particularly critical area 

Qualifications:

• Demonstrated experience in a blood center, blood banking, transfusion medicine, or related healthcare laboratory environment required.
• Bachelor’s degree in science or an allied science discipline.
• Minimum 5 years of Quality Assurance management experience.
• Medical Laboratory Scientist (MLS/ASCP) or Specialist in Blood Banking (SBB/ASCP) certification preferred.
• CMQ/OE or CQA certification through the American Society for Quality (ASQ) preferred.
• Strong leadership, communication, organizational, analytical, and problem-solving skills.
• Demonstrated ability to lead cross-functional quality initiatives and drive sustainable process improvement.

Other Relevant Information:

Will be required to comply with governmental regulations and strictly observe privacy and security related policies, procedures and practices to preserve the integrity and confidentiality of medical and other sensitive information pertaining to donors, patients, research subjects, and staff.  Will be required to enter areas where other individuals work with human blood; potential may exist for unanticipated exposure to bloodborne pathogens by splash or spill.

Background Check:

Final offers of employment are contingent upon the successful completion of a background check that includes employment history, national criminal background check.

We are not able to provide relocation or sponsorship for this position.

NBTC is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability.