Quality Manager-Louisville, Kentucky

4 weeks ago


Louisville, United States New York Blood Center Full time

Quality Manager-Louisville, Kentucky

Job Locations

US-KY-Louisville

Job ID

2024-6802

Category

Quality

Minimum Rate

USD $106,000.00/Yr.

Maximum Rate

USD $116,000.00/Yr.

Work Location Type

Physical

Overview

At New York Blood Center Enterprises (NYBCe), one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing needs of our diverse communities, further our lifesaving strategic goals in a rapidly changing environment, and expand our impact on the local, national, and global communities we serve.



Responsibilities

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.

  • 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.


Qualifications

Education:

  • Bachelor's degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management.
  • Bachelor's degree in another field of study may be considered with strong, relevant work experience.

Related Experience:

  • Minimum five years specialized experience (includes performing activities of a quality professional in a healthcare or drugs/biologics/medical devices manufacturing setting).
  • Minimum six years total relevant experience (includes any combination of:
    • specialized experience described above.
    • 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.
  • ASQ, Six Sigma or Lean Certification is a plus.
  • Experience as an ISO-9000, FACT, CAP or AABB Assessor is a plus.

Required Licenses / Certification:

  • Valid Driver's license with an acceptable driving record.

Any combination of education and experience equivalent to the requirements listed above has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job equivalent to the job requirements above.

For applicants who will perform this position in New York City or Westchester County, the proposed annual salary is $106,000.00p/yr. to $116,000.00p/yr. For applicants who will perform this position outside of New York City or Westchester County, salary will reflect local market rates and be commensurate with the applicant's skills, job-related knowledge, and experience.



  • Louisville, Kentucky, United States Britt Medical Search Full time

    Britt Medical Search is seeking a dedicated and compassionate Internal Medicine or Family Medicine Physician to join our team in Louisville, Kentucky. With its rich history, vibrant cultural scene, and world-famous bourbon industry, Louisville offers an attractive lifestyle for residents and visitors alike.We are offering a competitive salary of $250,000 per...


  • Louisville, United States Integrity Healthcare Full time

    Description: Multispecialty physician-led medical group Eight physicians and 8 APC's High volume endoscopy program Weekend call is 1:7 weekends EPIC EMR 8 hospitals with over 1,500 providers, including 800 physicians and more than 700 advanced practice clinicians. Comprehensive administrative and operations supports teams Physician leadership councils...


  • Louisville, Kentucky, United States Aequor Allied Full time

    Job OverviewAequor Allied is seeking a highly skilled MRI Technologist to fill a travel position in Louisville, Kentucky.Estimated Salary: $104,000 - $134,000 per 13-week contractThis opportunity offers a competitive tax-free stipend amount to be determined. The salary package is based on 12-hour shifts and 36 hours per week.Job ResponsibilitiesAs an MRI...


  • Louisville, Kentucky, United States The Medicus Firm Full time

    Located in the heart of Louisville, Kentucky, we are seeking a highly skilled Certified Registered Nurse Anesthetist (CRNA) to join our dynamic team at The Medicus Firm.About the Role:This is a full-time, permanent position with an estimated annual salary range of $180,000 - $220,000, depending on experience.You will be working in a Level 1 teaching...


  • Louisville, Kentucky, United States Britt Medical Search Full time

    Physician Opportunity OverviewWe are seeking a Board Certified/Board Eligible Family Medicine or Internal Medicine Physician to join our team in Louisville, Kentucky.Job SummaryThis is a full-time opportunity to provide excellent care to older adults in a medically underserved community. The ideal candidate will be intrinsically motivated to deliver...


  • Louisville, Kentucky, United States Norton Medical Group Full time

    Norton Medical Group is seeking an experienced Pediatric General Cardiologist to join our dynamic team at Norton Children's Heart Institute in Louisville, Kentucky.This exciting opportunity offers a unique blend of clinical and academic pursuits, allowing you to diagnose and treat pediatric cardiology conditions while contributing to the growth and...


  • Louisville, Kentucky, United States ADN Healthcare Full time

    Job Title: Travel Nursing Opportunity in Louisville, KentuckyWe are seeking a skilled and dedicated RN - Telemetry to join our team at ADN Healthcare. As a travel nurse with us, you will have the opportunity to work on 12 hour shifts, 36 hours per week, in a dynamic and fast-paced environment.About the Role:This is a 13-week contract position in Louisville,...


  • Louisville, Kentucky, United States TotalMed Staffing Full time

    TotalMed Staffing is seeking a travel nurse RN Telemetry for a long-term nursing assignment in the vibrant city of Louisville, Kentucky.About the RoleWe are looking for a skilled Registered Nurse-Telemetry to join our team for 13 weeks, working 36 hours per week. This exciting opportunity will provide you with a chance to gain valuable experience and expand...


  • Louisville, Kentucky, United States Care Team Solutions Full time

    We are seeking an experienced Registered Nurse (RN) for a travel nursing position in Louisville, Kentucky. This opportunity is perfect for those who enjoy working in a fast-paced environment and making a difference in the lives of others.About the JobThis role will involve working as a Progressive Care Unit (PCU) nurse in a reputable hospital. As a PCU...


  • Louisville, Kentucky, United States Planet Healthcare Full time

    Planet Healthcare is seeking a highly skilled travel nurse to join their team for a 13-week assignment in Louisville, Kentucky. This exciting opportunity offers a chance to work in the Telemetry department of a reputable hospital, providing top-notch care to patients and contributing to the success of the healthcare facility.About the RoleThis travel nursing...


  • Louisville, Kentucky, United States Medical Solutions Full time

    Job DetailsMedical Solutions is seeking a travel nurse RN PCU - Progressive Care Unit for a short-term assignment in Louisville, Kentucky.Key Responsibilities:Work in the PCU department of a hospital in Louisville, KentuckyProvide high-quality patient care as a registered nurseCollaborate with healthcare teams to ensure optimal patient outcomesWe're looking...


  • Louisville, Kentucky, United States HealthEcareers - Client Full time

    Galaxy Healthcare is seeking a travel nurse for a 13-week assignment in the vibrant city of Louisville, Kentucky. As a travel nurse with Galaxy Healthcare, you will have the opportunity to work in a dynamic and fast-paced environment, providing high-quality patient care while experiencing all that Louisville has to offer.About the AssignmentSpecialty: PCU -...


  • Louisville, KY, United States New York Blood Center Inc Full time

    Overview: At New York Blood Center Enterprises (NYBCe) , one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. Join us as we work towards meeting and exceeding the growing...


  • Louisville, Kentucky, United States Aureus Medical Group - Nursing Full time

    Telemetry Nursing Job in Louisville, KentuckyAureus Medical Group - Nursing is currently seeking a travel nurse RN Telemetry for an exciting opportunity in Louisville, Kentucky. This travel nursing position requires experience in Telemetry units and the ability to work effectively in a fast-paced environment.Salary: The estimated weekly payment breakdown for...

  • Critical Care Nurse

    2 days ago


    Louisville, Kentucky, United States Aureus Medical Group - Nursing Full time

    Job DetailsAureus Medical Group - Nursing is seeking a travel nurse RN Telemetry for a travel nursing opportunity in Louisville, Kentucky.


  • Louisville, Kentucky, United States Nurse First Full time

    We are seeking a skilled Operating Room Nurse to join our team at a prestigious healthcare facility in Louisville, Kentucky. As an OR nurse, you will be responsible for providing high-quality patient care during surgical procedures. This is a 13-week assignment with a guaranteed 36 hours per week and 12-hour shifts.The ideal candidate will have strong...


  • Louisville, Kentucky, United States Fusion Medical Staffing-Radiology Full time

    Company OverviewFusion Medical Staffing-Radiology is a leading healthcare staffing agency that connects talented professionals with exciting opportunities across the country. Our mission is to improve the lives of everyone we touch, and we're always looking for skilled individuals like you to join our team.About the RoleWe're currently seeking an experienced...


  • Louisville, Kentucky, United States MedPro Healthcare Staffing Full time

    Job Title: Travel Nurse Position in Louisville, KentuckyDescription:We are seeking a skilled Telemetry Registered Nurse for a travel assignment in Louisville, Kentucky.About the Role:This is a 13-week contract position with a 36-hour workweek, working 12-hour night shifts. The successful candidate will provide care to patients by connecting them to machines...


  • Louisville, Kentucky, United States The Curare Group Full time

    We are seeking an experienced Emergency Medicine Physician to join our team at The Curare Group. This is a permanent position based in Louisville, Kentucky, offering a competitive compensation package and a range of benefits.With a 16,000 annual patient volume, you will be working in a fast-paced environment with a 1.5:1 patient-to-provider ratio. Our...


  • Louisville, Kentucky, United States BrightStar Care of Louisville Full time

    Company Overview:BrightStar Care of Louisville is a reputable healthcare provider dedicated to delivering exceptional care services. Our team is comprised of compassionate professionals who prioritize patient well-being and strive to make a positive impact on their lives. Job Title: LPN Private DutySalary: $25-$30 per hour (dependent on experience and...