This role is responsible for ensuring the quality and safety of NYBCe products and services by applying expert knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment, and continuous improvement of work processes. This role will contribute to the design, implementation and management of the quality management system and lead QMS related projects and teams. This position serves as an expert resource, providing quality oversight and ensuring regulatory and accreditation compliance across multiple program areas, including blood and cellular therapy products manufacturing and distribution, clinical services, transfusion services, laboratory services, and clinical research, as well as organization-wide support functions such as information systems, facilities, and safety.
This position will be based in Louisville, Kentucky and candidate must be able to work in Louisville Kentucky.
- Manage programs and projects in assigned areas, including setting goals, measuring and reporting on performance, managing resources and budget
- Supervise staff, including work assignments, performance review, time and attendance, training, and mentoring.
- Protect the safety of patients and blood or HCT/P donors by notifying management and taking immediate action when a critical quality issue is identified that may warrant a stop to production and/or delivery of products and services.
- Contribute to the design and takes a lead role in the implementation and maintenance of the quality management system, including development, improvement and review of related SOPs, processes, IT solutions, and quality tools as assigned.
- Lead and independently perform quality assurance activities in support of NYBC enterprise-wide program areas.
- Ensure that appropriate specifications for NYBCe services and products have been defined according to their intended use, and verify that they consistently meet these defined specifications.
- Confirm that operational SOPs comply with applicable regulations, accreditation standards, and current NYBCe policy.
- Verify that document management and record keeping systems comply with regulatory and accreditation requirements.
- Review and approve validation studies for critical processes, equipment and computer systems to assure that they will consistently perform as expected.
- Verify that outside suppliers of reagents, materials and services used in critical processes are qualified according to NYBCe standards.
- Assist operational staff in the identification and reporting of deviations.
- Advise operational staff in root cause analysis, and the development of effective corrective action, preventive action, and effectiveness verification plans.
- Lead external regulatory and accreditation inspections, including preparation and follow up activities.
- Independently monitor and assess quality performance and compliance of operational systems.
- Manage deviation reporting process, including classification, analysis and follow up.
- Lead or participate in quality audits. Schedule and assign staff resources.
- Perform focused quality assessments of operational processes.
- Track, trend, analyze and report quality and process performance data.
- Contribute to process improvement efforts and lead team projects as needed.
- Advise staff on the development of corrective action and preventive action plans.
- Perform verification and effectiveness checks for CAPAs.
- Identify opportunities for improvement and make recommendations based on monitoring and assessment activities.
- Participate on formal process improvement team projects as assigned.
- Leads or actively participate in regularly scheduled quality management system review meetings with operational staff and managers.
- Advise and train NYBC staff in GMP and quality principles and in the use of quality tools.
- Assist with implementation, maintenance and monitoring of environmental health and safety activities as assigned.
- Work on special projects, individually and in a team, as assigned.
- Support management and/or serve as a system administrator of the eQMS software application and quality databases.
- Any related duties as assigned.