Blood Bank of Delmarva · 13 hours ago
Manager, Quality
Newark, DE
Full-time
Onsite
Mid, Senior Level
6+ years expThe Blood Bank of Delmarva is a division of New York Blood Center and a key provider of blood products and services. The Manager, Quality position is responsible for ensuring the quality and safety of products and services, managing quality management systems, and leading quality assurance activities across multiple program areas.
CommunitiesHealth CareNon Profit
Responsibilities
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
The incumbent may perform specialized duties requiring advanced or specialized knowledge and abilities in one or more of the following disciplines: Regulatory Affairs related to Blood, HCT/Ps, Medical Devices, CLIA, Distribution Pharmacy, and/or Clinical Trials at the State and Federal levels, Environmental Health and Safety Program, Document and Records Management Program, Education and Training Programs, Software application configuration management / database management
Any related duties as assigned
Qualification
Required
Bachelor's Degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management
Minimum 5 years specialized experience (includes performing activities of a quality professional in a healthcare or drugs/biologics/medical devices manufacturing setting)
Minimum 6 years total relevant experience includes any combination of specialized experience described above, and clinical or technical work performed in a healthcare, laboratory, or drugs/biologics/medical devices manufacturing setting
Minimum one year management experience (includes supervision, project management, and/or program management)
Valid Driver's license with an acceptable driving record
Preferred
ASQ, Six Sigma or Lean Certification is a plus
Experience as an ISO-9000, FACT, CAP or AABB Assessor is a plus
Benefits
Full Benefits
Company
Blood Bank of Delmarva
Blood Bank of Delmarva community-based nonprofit blood center that provides blood and blood products.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase