The Be The Match Seattle Collection Center is an apheresis facility owned and operated by NMDP/Be The Match for the collection of hematopoietic stem cells. The on-site Quality Manager is responsible for maintaining quality systems and regulatory compliance at the Collection Center, in support of NMDP / Be The Match strategic goals. Primary duties are focused on the Quality Management System and Quality Operations within the scope of FDA and state regulations and accreditation standards including FACT, NMDP, WMDA, and CAP. The Quality Manager will lead the quality activities of the center by prioritizing objectives, managing regulatory and compliance needs, leading quality inspections, and establishing a quality culture at the site.
ACCOUNTABILITIES:
Quality Assurance Oversight:
Ensures facility operations are conducted in compliance with all applicable regulations and standards.
Provides guidance to operations management and staff regarding regulatory and quality system requirements.
Develops and revises site Quality Plan as well as site-specific quality processes and procedures.
Leads and oversees CAPA activities; works closely with NMDP Medical Services and QA teams to ensure timely investigation and resolution of problems and complaints.
Oversees change control implementation and manages approved variances.
Determines immediate and short-term remedial actions when problems/incidents or deviations occur.
Oversees Seattle site supplier qualification process and monitors/reviews approved supplier list.
Approves site SOPs and related documents; approves validation plans and reports.
Compiles, analyzes, and provides regular reports on quality systems functions and metrics.
Audits and Inspections:
Prepares for, hosts, and responds to audits and inspections of Seattle facility.
Prepares and leads site through FACT, CAP, and other applicable accreditation process.
Training:
Develops and delivers quality/compliance training; contributes to process improvements with site specific input.
Ensures site personnel training and competency records are complete, accurate, and up to date.
Quality Control:
Oversees, monitors, and reviews Quality Control activities and records.
Reviews collection records and releases product for distribution.
REQUIRED QUALIFICATIONS:
Knowledge of:
Expert knowledge of quality systems and quality management, including QA and QC functions.
Apheresis and cell therapy applications.
FDA Biologics, Drug and Tissue regulations (including GMP/GTP), HIPAA, and other applicable regulatory requirements.
Accreditation requirements for FACT, CAP, or similar accrediting bodies.
CLIA requirements for high complexity testing.
Ability to:
Demonstrate excellent oral and written communication and advanced interpersonal collaboration skills.
Effectively interact with inspectors and auditors.
Solve complex problems making timely and sound decisions.
Handle multiple issues with flexibility and appropriate prioritization.
Exhibit strong customer service skills
Must exemplify our Be the Match Standards.
Education and/or Experience:
Bachelor’s degree, biomedical, scientific, or regulatory field preferred.
At least 10 years progressively responsible quality management experience in regulated environments (biomedical and/or healthcare), with at least 3 years in a leadership role.
At least 2 years’ experience with development and execution of validation plans and protocols for medical and/or laboratory equipment.
PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
ASQ/RAC/Exemplar certification.
ASCP certification.
Experience successfully leading FACT, CAP, CLIA or similar accreditation efforts.
Experience in apheresis collection center activities.
Knowledge of emerging cell and gene therapies.
Knowledge of biopharmaceutical cell therapy development and approval process.
Internal Number: 21000001
About Be The Match
Be The Match is a non-profit organization that delivers cures to patients in need of life-saving blood stem cell therapy. The organization operates the national Be The Match Registry®, the world’s largest and most diverse listing of potential stem cell donors. As trusted leaders in advancing stem cell therapy, Be The Match also provides ground-breaking research, innovative technologies, patient support, and education so even more lives can be saved.
