Director, Quality Assurance
Company: NDRI - National Disease Research Interchange
Posted on: November 15, 2019
Reporting to thePresident/CEO ,the Director, Quality Assurance is
responsible for the planning,administration, and monitoring of
consistent readiness of all qualitymanagement, regulatory
compliance and quality improvement processes. He/shewill guide the
QA department to conduct quality assurance audits andsurveillance;
conduct quality assurance investigations of
nonconformingproducts/processes and coordinate corrective actions
according to NDRI's Problem Management procedures. This
positionrequires an experienced leader, to manage the NDRI'sGlobal
Quality program andsupport the organization's commitment to the
maintenance of NDRI's QualitySystems stipulated in the Quality
Manual in accordance with federal, state, andother regulations and
requirements. Additionally, this Director will be a member of the
Executive Management Team.
SALARY COMMENSURATE WITH EXPERIENCE $90,000-$100,000 --- Essential
Reasonable accommodations may be made to enableindividuals with
disabilities to perform the essential functions.
1. Overseequality assurance functions in accordance with the NDRI
Quality Manual andNDRI's mission.
2.Promotecontinual improvement, quality achievement, and
performance improvementthroughout NDRI projects and programs.
3. Superviseand administer the activities of the Quality Assurance
staff to effectivelyachieve NDRI's mission.
4. Ensurethe integration of quality in operational processes and
practices through the reviewand evaluation of practices within
procedures, data base accuracy, hard copydonor records, and tissue
source site compliance as required in the NDRIQuality Manual and
5. Design,interpret, and implement Quality Assurance systems and
practices in accordancewith federal, state, and other regulations
6. Monitor,report and make recommendations for improvement to NDRI
management trends, andnon-conformances/deviations via the Problem
Management System, Quality SystemReviews, operationally-related
accidents/incidents (in coordination with HR),and customer
7. Coordinatewith Business Development opportunities to ensure
integration of implementedquality assurance practices.
8. Managethe employee training program as it applies to the Quality
Management System(QMS); identify relevant training needs by
implementing training programs toassure compliance with NDRI
standard operating procedures.
9. Responsiblefor tissue source site qualification activities.
10. Responsible for the review of equipmentvalidation, including
guidance to ensure the validation activities meet therequirements
of NDRI's Quality Manual and Quality Policy and its customers.
11. Responsible for all Quality Assurancestandards and final
approval of NDRI policies and procedures.
12. Maintain current and accurate records ofall relevant
communications, audits, corrective action plans, and
This position is responsible for the directsupervision of NDRI's
Quality Assurance Specialist.
This position requires up to 25% travel. Frequently travelis
outside the local area and overnight.---o Master's degree is
required with 7-10 years of quality program management experience.o
Minimum 7-10 yrs. 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 Demonstrated competency in
computer skills: MS office applications, query tools, and
enterprise database systems
- Self-motivated, able to accomplish multiple assignments
- Understands the principles of an efficient and effective
quality program and can develop and implement same.
- Strong organizational and problem-solving skills
- Must be able to communicate appropriately and adequately to all
management levels, including group presentation experience
- Demonstrated experience/results in Quality System tools and
- Advanced computer skills
NDRIprovides equal employment opportunities (EEO) to all employees
and applicantsfor employment without regard to race, color,
religion, sex, national origin,age, disability or genetics. In
addition to federal law requirements, NDRIcomplies with applicable
state and local laws governing nondiscrimination inemployment in
every location in which the company has facilities. This
policyapplies to all terms and conditions of employment, including
recruiting,hiring, placement, promotion, termination, layoff,
recall, and transfer, leavesof absence, compensation and training.
NDRI expressly prohibits any form of workplace harassment based on
race,color, religion, gender, sexual orientation, gender identity
or expression,national origin, age, genetic information,
disability, or veteran status
Job Type: Full-time
Keywords: NDRI - National Disease Research Interchange, Lower Merion , Director, Quality Assurance, Executive , Philadelphia, Pennsylvania
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