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Director, Quality Assurance

Posted on Dec 19, 2019 by National Disease Research Interchange

Philadelphia, PA 19103
Health Care
Immediate Start
Annual Salary
Full-Time
Reporting to the President/CEO , the
Quality Assurance Director will provide leadership and strategic
direction for all NDRI quality programs. The director is
responsible for development and maintenance of all quality
assurance programs, plans and procedures. He/she will guide the QA
department to conduct quality assurance audits and surveillance;
conduct quality assurance investigations of nonconforming
products/processes and coordinate corrective actions. This position
requires an experienced leader, to manage the NDRI's Global Quality
program and support the organization's commitment to the
maintenance of NDRI's Quality Systems stipulated in the Quality
Manual in accordance with federal, state, and other regulations and
requirements.
1. Oversee quality assurance
functions in accordance with the NDRI Quality Manual and NDRI's
mission.
2. Promote quality achievement, and
performance improvement throughout NDRI projects and programs.
3. Supervise and administer the
activities of the Quality Assurance staff to effectively achieve
NDRI's mission.
4. Ensure the integration of
quality operational processes and practices through the review and
evaluation of practices within procedures, data base accuracy, hard
copy donor records, and tissue source site compliance as required
in the NDRI Quality Manual and Quality Policy.
5. Design, interpret, and implement
Quality Assurance systems and practices in accordance with federal,
state, and other regulations and requirements.
6. Provide leadership and oversight
with applicable accreditation and licensing agencies, e.g., College
of American Pathologists (CAP), American Association of Tissue
Banks (AATB), and New York State Department of Health- Wadsworth
Center.
7. Monitor, report and recommend to
NDRI management any trends, and non-conformances/deviations via the
Problem Management System, Quality System Reviews, and customer
complaints.
8. Collaborate with Human Resources
on the reporting and review of internal accidents and
incidents.
9. Coordinate with Business
Development opportunities to ensure integration of implemented
quality assurance practices.
10. Manage the employee training program as it applies to
the Quality Management System (QMS); identify relevant training
needs by implementing training programs to assure compliance with
NDRI standard operating procedures.
11. Responsible for tissue source site qualification
activities.
12. Responsible for all Quality Assurance standards and
final approval of QA policies and procedures.
13. Maintain current and accurate records of all relevant
QA communications, audits, corrective action plans, and
effectiveness monitoring.
Experience
o Master's degree is required; with 5 years
experience in Quality Systems Management Implementation, QA
Administration, and QA Audit process and in a medical
research-related environment.
o Quality related certifications required;
Certified Tissue Bank Specialist (AATB) and/or
Certified Quality Auditor (ASQ)
o Experience with accreditation and
quality requirements and regulations such as National Committee for
Quality Assurance (NCQA), College of American Pathologists
(CAP)
o Strong
knowledge of investigations, problem solving and corrective action
implementation.
SALARY - $90,000-$100,000 (COMMENSURATE WITH
EXPERIENCE)

Reference: 814638484

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