The Supervisor, Quality External Audits works with internal staff, Network partners, and Be The Match BioTherapies (BTMBT) clients to assess and improve compliance of operational processes and systems, in support of NMDP’s strategic objectives. This role assures continuing compliance with cellular therapy regulations and promotes highest standards of safety for donors, patients and products. Primary compliance accountabilities include oversight of the QRS Audit Program for NMDP core business and new business development, participation in the AC qualification process and active engagement in strategic planning regarding the audit process.
Oversight of QRS Audit Program:
Oversees external quality audit program which includes audits of donor centers, apheresis centers, and contracted laboratories on behalf of NMDP and/or clients.
Oversees the scheduling and coordination of external quality audits.
Reviews and approves annual master audit schedule, audit reports and audit follow-up activities; ensures appropriate resolution of audit findings and corrective actions.
When staffing/scheduling requires, performs AC qualification audits, works with auditees, QRA staff, clients, and NMDP leadership to perform audit follow-up.
Contributes to process development and software implementation.
Quality Systems Audit Program (QSAP):
Works closely with Cell & Gene Therapy and other departments to implement and administer commercial Quality Systems Audit Program.
Training and Standard Operating Procedures/Policies:
Trains staff on the audit process; assists auditors with audit reports and audit follow-up.
Creates, revises, and reviews procedures and tools applicable to the audit process.
Other duties as assigned, in support of NMDP’s mission and goals.
Leadership and Supervision:
Oversees team productivity and performance.
Selects, interviews, and hires new team members in collaboration with QRA leadership and stakeholders.
Conducts performance evaluations and establishes performance/development goals.
Advanced applied knowledge of auditing principles and practices in an FDA regulated industry such as biologics, blood, tissues, pharmaceutical or medical device.
Knowledge of Good Manufacturing Practices (GMP) required and Good Tissue Practices (GTP) desired.
Knowledge of contract manufacturing principles and practices desired.
Think analytically and critically; communicate and collaborate with internal stakeholders and with external partners and clients.
Demonstrate strong technical writing skills and proficiency with Microsoft Office applications.
Meet deadlines and manage multiple tasks and projects simultaneously; ability to actively engage in strategic planning regarding audit process.
Demonstrate strong interpersonal skills; work independently and as part of a team.
Lead diverse team and drive high performance.
Commit to overnight travel of approximately 1-2 trips per month.
Education and/or Experience:
Bachelor’s degree in medical technology, biology, biotechnology or other health-science related field. Auditor certification required.
Seven years of experience as an auditor in an FDA-regulated industry such as biologics, blood, tissues, pharmaceutical or medical device.
Two years of experience in a supervisory/leadership position.
Experience with quality management software, particularly audit and supplier management.
Experience leading remote teams.
Internal Number: 1900008R
About Be The Match
We’re trusted leaders in the field of cellular therapy. We never lose sight of our purpose—delivering cures for blood cancers. From the moment a patient is diagnosed, we are there every step of the way; helping their doctor find a donor, delivering life-saving cells to the patient’s bedside, and supporting patients through recovery and survivorship.
With over 30 years of experience, we are the trusted leaders in advancing the science of transplant, conducting ground-breaking research and providing vital services for patient families when they need them most.
As the world’s largest registry and hub of a global network, our partners count on us to develop innovative solutions to improve transplant and fuel collaborative relationships essential to saving lives.