Manager, Quality Assurance and Compliance

About us

Founded in 1979, Rhode Island Blood Center (RIBC), operated by New York Blood Center Enterprises, is a nonprofit community blood center, delivering nearly 100,000 lifesaving blood products to 50+ hospitals, EMS and healthcare partners across New England annually. To learn more, visit ribc.org/about-us.

Make a Difference…Save a Life…in our local communities and beyond. Are you passionate about making a difference in your community? Interested in saving lives close to home? The Rhode Island Blood Center and the Connecticut Blood Center are divisions of New York Blood Center Enterprises, one of the most preeminent and comprehensive blood centers in the world. Become part of the life-saving mission of providing patients with access to a safe, adequate and effective blood supply in our local communities and beyond.

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.
  

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, 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

• ASQ, Six Sigma or Lean Certification is a plus.
• Experience as an ISO-9000, FACT, CAP or AABB Assessor is a plus.
• Valid Driver’s license
  
  
  

The proposed wage for this position is $102,000 - $112,000.