Assistant Director

Quality Assurance for Cellular Therapies

The University of Cincinnati's, Hoxworth Blood Center is seeking an experienced Assistant Director to assist with the Quality Assurance activities that support our FACT-accredited, Collection Facility and Cell Therapy Processing Laboratory. Our program currently supports four stem cell transplant programs, cell processing and cell engineering applications, and innovative immunotherapies and regenerative medicine clinical trials. We are committed to providing quality products and services to the patients we serve and seek a dedicated Quality Assurance professional to assist with the management of a robust quality management plan.

Overview

The Assistant Director of Quality Assurance plays a critical role in maintaining our Cell Therapy program's accreditation status and inspection readiness. In partnership with Operations department managers, this position is responsible for ensuring compliance with applicable regulations, hosting and responding to external audits, conducting internal audits, tracking quality indicators, managing quality agreements with clinical partners, and other quality assurance functions that support our Cell Therapy Program.

Responsibilities

• Manage a Quality Management Plan that is in compliance with current Good Tissue Practice and Good Manufacturing Practice regulations, as well as FACT and AABB Standards.
• Review production batch records and release products for infusion.
• Perform internal audits designed to detect opportunities for process improvement.
• Lead QA/Collections/Processing team in external audit process, including managing advance preparations and response submissions.
• Assist with deviation root cause analyses and CAPA implementations. Determine effectiveness of corrective actions.
• Provide quality assurance oversight to negotiations and implementation of quality agreements with hospitals and drug manufacturers to support industry-sponsored clinical trials.
• Assist with developing and delivering quality-related training programs for staff.
• Conduct supplier qualifications and periodic audits of critical materials suppliers. Inspect and release critical raw materials prior to use.
• Review and approve SOP's and validation protocols.
• Support department managers and work as a team to support Hoxworth's mission of providing high quality cell therapy products.

The desired qualifications are a Bachelor's degree with five years experience in a health care or pharmaceutical quality management setting. ASQ certification or equivalent is strongly desired.

Minimum Qualifications :

Bachelor's degree with five (5) years experience; OR Associate's degree with seven (7) years experience; OR nine (9) years experience. Degree andexperience must be in a related field. Experience also requires at least three (3) years supervision.

Hoxworth Blood Center is the only university-owned blood center in the United States and is an academic unit of the University of Cincinnati. Hoxworth is an FDA-registered supplier of blood and blood components to 31 regional hospitals and provides therapeutic apheresis services and cellular therapy product collection and processing services for the hematopoietic stem cell transplant programs at Cincinnati Children's Hospital Medical Center, University of Cincinnati Academic Health Center, Jewish Hospital, Akron Children's Hospital, and the NMDP.

The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.

As a UC employee, and an employee of an Ohio public institution, if hired you will not contribute to the federal Social Security system, other than contributions to Medicare. Instead, UC employees have the option to contribute to a state retirement plan (OPERS, STRS) or an alternative retirement plan (ARP).

The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / M / F / Veteran / Disabled.

REQ: 32943

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Nearest Major Market: Cincinnati
Job Segment: Manager, Medical, Engineer, Quality Manager, Quality, Management, Healthcare, Engineering



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