Rush University Medical Center

Location: Chicago, Illinois

Business Unit: Rush Medical Center

Hospital: Rush University Medical Center

Department: Bone Marrow Transplant

Work Type: Full Time (Total FTE between 0.9 and 1.0)

Shift: Shift 1

Work Schedule: 8 Hr (8:00:00 AM - 4:30:00 AM)

Rush offers exceptional rewards and benefits learn more at our Rush benefits page (https://www.rush.edu/rush-careers/employee-benefits).

Pay Range: $50.15 - $81.62 per hour

Rush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. The pay range for each role reflects Rush’s anticipated wage or salary reasonably expected to be offered for the position. Offers may vary depending on the circumstances of each case.

Summary:

The Manager of Quality, Bone Marrow Transplant is serves as a member of the Bone Marrow Transplant leadership team, with focus on the development and execution of all quality management activities for all divisions of the Bone Marrow Transplant Quality Program. The position encompasses project management, consultation, facilitation, data abstraction, analytics and interpretation. Exemplifies the Rush mission, vision, and values and acts in accordance with Rush policies and procedures.

Other information:

Required Job Qualifications:

• Bachelor’s from an accredited college or university in a scientific, healthcare, or other relevant field required.
• At least 5-7 years of experience in a hospital or a related health care environment with experience in transfusion medicine and/or cellular therapy.
• Experience with FACT, CAP, AABB and/or FDA inspections.
• Experience in quality assessment, process improvement and project management.
• Ability to effectively coordinate and manage teams and projects.
• Flexibility to meet organizational goals and adapt to changing needs. Ability to meet internal and external customer needs.
• Ability to perform tasks independently and prioritize workloads. Ability to work on multiple projects simultaneously.
• Must strive for excellence and be able to motivate teams towards excellence.

Preferred Job Qualifications:

• Clinical experience in field of cellular therapy such as nursing, medical technology, or regulatory
• Training in Lean Six Sigma or other process improvement preferred.

Disclaimer: The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.

Responsibilities:

• Develops and maintains the SCT Quality Plans ensuring compliancy with all regulatory and accreditation requirements as well as activities related with the accreditation of the program with State, Foundation for the Accreditation of Cellular Therapy (FACT), Center for International Blood and Marrow Transplant Research (CIBMTR), National Marrow Donor Program (NMDP), American Society for Transplantation and Cellular Therapy (ASTC), Food and Drug Administration (FDA), College of American Pathologists (CAP) and Centers of Excellence programs.
• Plans, prepares, and conducts high-level compliance audits for regulatory agencies to assess risk and identify process improvement gaps to ensure we compliance with current standards.
• Oversees and enhances the quality and accreditation activities of the program.
• Develops, implements, and manages the Quality Management Plans (QMP) and related processes for Stem Cell Therapy including corrective action planning, change control, deviations, and risk management.
• Ensures compliance with the quality assurance and quality control procedures including SOP approval, SOP scheduled reviews, and validation of new equipment, processes, and procedures.
• Oversees the completion of look-back investigations and biologic market withdrawals and guides reporting of biologic product deviations to the FDA and other outside partners.
• Collaborates with the RUMC Office of Risk Management to review external errors and assist in process improvement as appropriate.
• Coordinates and partners with outside organizations for disaster planning and implementing memorandums of understanding. Serves as the safety officer for the Cell Processing Laboratory. Coordinates with RUMC’s Emergency Management team for disaster planning.
• Manages the on-boarding process for new commercial cell therapy products, ensuring seamless integration into existing quality systems and regulatory requirements.
• Acts as account representative for outside manufacturing partners for cellular therapies to ensure staff training, patient education and documentation is completed per regulatory requirements. Includes management of internal and external audits.
• Manage clinical trials portfolio and coordinate participation in clinical trials and offering of cell therapy services to ensure both operational efficiency and adherence to quality assurance standards.
• Assistance clinical investigators with the FDA and IRB application submissions and query responses.
• Lead and mentor the Quality and data coordinator teams, including day-to-day supervision and staff development.
• Serve as subject matter expert as needed for projects related to cellular therapy growth or improvement initiatives. Partners with multidisciplinary teams to execute and drive performance improvement opportunities.
• Maintains current knowledge on published standards, guidelines, and literature on Cellular Therapy, GTP and GMP. Develops addition of GMP quality activities into current QMP.

Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.