Director Quality and Regulatory Compliance - Regional Midwest

Summary

This role is responsible for ensuring the quality and safety of products and services across multiple Divisions of NYBCe (Midwest Region - Memorial Blood Centers, Nebraska Community Blood Bank, and Community Blood Center) by applying expert knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment, and continuous improvement of work processes. This role is responsible for overseeing and approving the design, implementation, maintenance, and management of the quality management system. This role will lead QMS related projects and 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.

Job Details

• Collaborate with executives and/or senior management in defining organizational goals and action plans.
• Manage budget for the Quality Management System Team.
• 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 advising subordinates as needed 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.
• Approve the design and oversee the implementation and maintenance of the quality management system, including development, improvement and review of related SOPs, processes, IT solutions, and quality tools.
• Participates in review and approval of supplier and customer agreements as assigned to ensure that quality expectations are addressed.
• Collaborates with peers across all organizational divisions to harmonize quality policies and approaches and coordinate implementation of new or changes procedures.
• Direct and independently perform quality assurance activities in support of NYBCe 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.
• Ensure control of nonconforming products. Manage handling and notifications of quarantines, recalls and market withdrawals.
• Confirm that operational SOPs comply with applicable regulations, accreditation standards, and current NYBCe policy.
• Manage change to address stakeholder needs, resource needs, and maintain ongoing compliance.
• 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.
• Direct and independently monitor and assess quality performance and compliance of operational systems.
• Manage deviation reporting process, including classification, analysis and follow up
• Lead quality audits. Ensure the effectiveness of the audit program.
• Track, trend, analyze and report quality and process performance data, and makes recommendations based on data analysis and conclusions
• Lead improvement projects dealing with broad or complex issues, or with strategic impact.
• Advise staff on the development of corrective action and preventive action plans.
• Perform verification and effectiveness checks for CAPAs.
• Identify opportunities for improvement and makes recommendations based on monitoring and assessment activities.
• Lead or actively participate on formal process improvement team projects as assigned.
• Lead or actively participate in regularly scheduled quality management system review meetings with operational staff and managers.
• Ensure that the organization’s training needs are assessed, met and in compliance with applicable regulatory requirements and accreditation standards.
• Develop and deliver training to NYBCe staff in regulatory, GMP and quality principles and in the use of quality tools. Serves as an expert resource to staff.
• Report to top management on the performance of the quality system and any need for improvement.
• Serve as an authorized official representing the organization to regulatory and accrediting agencies, including FDA, CMS and State Departments of Health.
• Participate in preparing comments on draft regulations and standards to agencies and professional organizations.
• Prepare and submit regulatory registrations, submissions and amendments to support operations as assigned.
• Maintain records of regulatory communications and filings.
• Identify regulatory risks, communicate them to management, and facilitate the development of mitigation strategies as appropriate.
  
  

Hybrid Work is in office three days per week at either St. Paul, Lincoln, or Kansas City office. Travel to other supporting areas in the mid-west would be approximately once a quarter.

Education

Bachelor’s Degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management

Related Experience

Minimum seven years specialized experience (includes performing activities of a quality professional in a healthcare or drugs/biologics/medical devices manufacturing setting).

Minimum ten 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 five years management experience (includes supervision, project management, and/or program management).

Preferred Qualifications

ASQ, Six Sigma or Lean Certification is a plus.

Experience as an ISO-9000, FACT, CAP or AABB Assessor is a plus.

License

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.

Founded in 1964, New York Blood Center Enterprises (NYBCe) has provided more than 60 years of lifesaving research, innovation, and impact. NYBCe is one of the largest nonprofit blood centers, spanning 17 states and serving 75 million people. NYBCe operates Blood Bank of Delmarva, Community Blood Center of Kansas City, Connecticut Blood Center, Memorial Blood Centers, Nebraska Community Blood Bank, New Jersey Blood Services, New York Blood Center, and Rhode Island Blood Center, delivering one million blood products to 400 U.S. hospitals annually. NYBCe additionally delivers cellular therapies, specialty pharmacy, and medical services to 200 research, academic, and biopharmaceutical organizations. NYBCe’s Lindsley F. Kimball Research Institute is a leader in hematology and transfusion medicine research, dedicated to the study, prevention, treatment and cure of bloodborne and blood-related diseases. NYBCe is a vital community lifeline dedicated to helping patients and advancing global public health. To learn more, visit nybce.org. Connect with us on Facebook, X, Instagram, and LinkedIn.