Manager, Quality Systems, Medical Technologist, Regulatory Affairs Specialist
4 Year Degree
Kentucky Blood Center, located in Lexington, Kentucky, is seeking a Director of Quality Assurance (QA) to support the oversight of the organization’s compliance program. This critical management position reports to the Vice President, Quality and Regulatory Affairs, and provides day to day supervision of the QA department, directing employees and key functions. It is responsible for steering adherence to standards issued by regulatory agencies and accrediting organizations, and will guide compliance with applicable AABB, FDA, CLIA, State, OSHA, EU, and Short-Supply Agreement requirements.
The role is essential in maintaining a safe blood supply, and in ensuring the safety of KBC stakeholders (employees, donors, blood recipients). Strong attention to detail is vital in this position, with exceptional analytical, documentation, and reporting skills, combined with competency in the development and execution of auditing methods and systems. Must demonstrate the ability to compose, interpret, and implement Standard Operating Procedures (SOPs), and to identify when revisions and process changes are necessary due to regulatory requirements, or business need. The role will review employee training plans and may participate in the delivery of training sessions on compliance topics. Occurrence management is a core responsibility and involves review, tracking, investigation, and corrective action activities. Participates in regulatory investigations, acting as an inspection liaison as directed, and may represent KBC on committees as determined necessary by executive leadership. The ideal candidate will possess high level interpersonal and skills, and will be able to effectively communicate and provide guidance at all levels of the organization.
Required credentials are an MT (ASCP), with a minimum of 5 years of experience in a related quality assurance management background. Individuals with supervisory experience in coaching and leading teams is preferred. Blood banking industry knowledge highly desired. Strong Microsoft Office skills and knowledge of general compliance and regulatory practices are required, with occasional travel.
Competitive salary, comprehensive benefits including health, dental, vision, life, STD, LTD, paid time off/holidays, EAP, and 401(k) retirement savings plan. Relocation provided. For more information or to apply online, please visit www.kybloodcenter.org. Drug-free and EOE/AAP.
About Kentucky Blood Center
KBC, founded in 1968, is the largest independent, full-service, non-profit blood center in Kentucky. Licensed by the FDA, KBC's sole purpose is to collect process and distribute blood for patients in Kentucky hospitals.
ONLY APPLICATIONS SUBMITTED AT: http://www.kybloodcenter.org WILL BE ACCEPTED.