MD Anderson Cancer Center Mgr, Cord Blood Bank Quality in Houston, Texas
Mgr, Cord Blood Bank Quality
Location: United States, Texas, Houston, Houston (TX Med Ctr) at https://mdanderson.referrals.selectminds.com/jobs/4990/other-jobs-matching/location-only
Managerial/Professional at https://mdanderson.referrals.selectminds.com/landingpages/managerialprofessional-opportunities-at-md-anderson-cancer-center-11
Cord Blood Bank Program 600727
Requisition #: 109407
The Cord Blood Bank Quality Manager ensures the Cord Blood Bank adheres to regulatory standards at the federal, state, local and institutional levels. This role impacts Cord Blood Bank compliance and accreditation status and interactions with national and international registries and transplant centers.
1) Cleanroom Facilities
a. Ensure environmental monitoring is performed, under both static and dynamic conditions, including during production of the biological product, trended and acted upon, to include, but not limited to, microbiological and particle levels. Collaborate with MD Anderson’s housekeeping department to ensure the facility is cleaned to appropriate standards by staff trained and competent to clean and sanitize the classified areas.
b. Maintain an aseptic processing facility monitoring program of both facility and personnel.
c. Review and monitor performance indicator data relating to the cleanroom facility to identify, develop and implement quality and process improvement.
d. Develop, implement and manage training, qualification and monitoring of staff using the cleanroom facility, including, but not limited to, access, gowning, hygiene, aseptic technique, cleanroom behavior and patient safety hazards posed by a non-sterile biological drug product.
e. Ensure Employee and Environmental Health and Safety implications of CB banking activities are properly managed as required by institutional and external regulatory guidelines.
f. Work closely with Institutional Facilities to ensure CBB facility is maintained according to FDA guidelines meeting Biological Licensure requirements.
g. Performs required environmental monitoring and reports discrepancies to leadership.
2) Manage CBB Quality Operations - QC laboratory:
a. Maintain quality operations to effectively handle daily workload as required by regulatory agencies (FDA, FACT, and CAP).
b. Support regulatory requirement to improve and develop systems for selection of units for transplantation and shipment of cord blood units to transplant centers including required documentation and review. Maintains and enforces compliance with current Good Manufacturing Practice (cGMP) and best industry practice.
c. Maintains adequate quality control and testing performed by qualified/accredited/licensed facilities and personnel including documentation and review of training and competency records.
d. Maintain a source of research material for approved internal and external research groups with required documentation.
e. Maintain and develop efficient, high quality systems for documentation and review of CB donations collected, processed, stored, listed and provided for transplantation or research.
3) Manage CBB Quality personnel:
a. Develop, implement and manage staff training, development, appraisal and technical proficiency, monitoring training and competency ensuring regulatory compliance.
b. Develops, implements, and manages an efficient, accurate and sustainable inventory management system as required by regulatory agencies system; including supplies, reagents and equipment, CB products and reference samples with required documentation and review.
c. Manage interactions with providers of services for CBB, both internal and external to MDACC. Perform scheduled audits of suppliers as required by regulatory agencies.
d. Collate and report quality indicator data for testing and issuance activities of the bank.
Quality Assurance (QA)/Quality Control (QC)
1) Maintains and enforces requirements of the Quality Unit ensuring regulatory (FDA, FACT, and CAP) preparedness at all times.
2) Maintains procedures and documents in compliance with current Good Laboratory Practice (cGTP), cGMP and current Good Tissue Practice (cGTP) regulations and applicable accreditation agency standards, including but not limited to FDA, FACT-NetCord, CAP and CLIA.
3) Develops and implements comprehensive continuous quality improvement systems, including: deviation and event reporting, risk assessment, change control, corrective action and preventative action (CAPA) and document control.
4) Manages and enforces compliance with safety guidelines, policies and procedures, according to applicable institution and state and federal agencies.
5) Monitor activity levels and performance indicators for banking activities to identify, develop and implement quality and process improvement projects.
6) Prepare responses to audit and inspection deficiencies and develop corresponding improvement plans.
Customer Service/Communication and Product and Records Management
1) Liaise with NMDP/CIBMTR to facilitate data collection associated with release of CB units to transplant centers and follow-up of recipient.
2) Participate in regular meetings with senior management team, coordinating and communicating effectively with peers, and others, to accomplish goals. Ensure maximum coordination of efforts.
3) Provides timely communication of relevant information to CBB personnel and maintains communication between activities.
4) Must have outstanding interpersonal, communication and customer service skills, excellent verbal communication skills, excellent organizational skills, attention to detail and good writing skills.
5) Manage testing of product; including follow-up of outstanding results, resolution of reactive/abnormal results, reporting to physicians and/or appropriate agencies as applicable.
6) Coordinate and liaise with appropriate parties to manage the electronic submission of the required documentation and data for accreditation, licensing and post marketing activities such as clinical outcome data, changes, biological product deviations and adverse experiences, including but not limited to the FDA Biologics Licensure Application (BLA), Investigational New Drug (IND) applications, CAP, CLIA and FACT.
Required: Bachelor's degree in biological sciences or related field.
Required: Seven years of experience of progressive health care or clinical laboratory experience to include three years of supervisory experience.
Preferred: Cord blood bank experience.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html