Director, Quality Assurance

National Disease Research Interchange

Posted: 11/6/2019

Position Type: Full-Time (Paid)

Function: Policy

Primary domain: Research

City: Philadelphia

Postal code: 19103

State: Pennsylvania

Country: United States

Organization Information:

Budget:

$3M - $10M

Website:

www.ndriresource.org

Mission statement:

The mission of NDRI is to provide human biospecimens worldwide to advance biomedical/bioscience research and development and education in the life sciences.

Founded in 1980, the National Disease Research Interchange (NDRI) is a 501(c)(3) not-for-profit organization that provides human biospecimens to scientists in academic, corporate and independent research organizations throughout the world. We serve as a Human Tissue and Organ for Research Resource (HTORR). The National Institutes of Health (NIH) has supported our work for more than 30 consecutive years. Our unparalleled tissue recovery network includes some 130 partners comprised of organ procurement organizations, eye banks, tissue banks and hospitals, and our biorepository facility is accredited by the College of American Pathologists (CAP). Utilizing the expertise of NDRI staff and that of our recovery partners, we provide anatomical structures, organs, and tissues with annotated data to support research across the full spectrum of disease and disability.

Since our founding, we have been committed to expanding the horizons of medical knowledge. We continue to do so today, with an array of programs designed to provide human tissues and organs to meet critical research needs. We are grateful for the support we receive from the National Institutes of Health and other public and private funding sources, from our expansive nationwide network of recovery partners, and through the generosity of patients and families who want to contribute to finding answers to today’s most pressing biomedical challenges.

Position Details:

Job Description:

Reporting to the President/CEO, the Director, and Quality Assurance is responsible for the planning, administration, and monitoring of consistent readiness of all quality management, regulatory compliance and quality improvement processes. 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 according to NDRI’s Problem Management procedures. 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.

Essential Functions

1.Oversee quality assurance functions in accordance with the NDRI Quality Manual and NDRI’s mission.

2.Promote continual improvement, quality achievement, and performance improvement throughout NDRI projects and programs.

3. Supervise and administer the activities of the Quality Assurance staff (one) to effectively achieve NDRI’s mission.

4.Ensure the integration of quality in 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.Experience with accreditation and quality requirements and regulations such as National Committee for Quality Assurance (NCQA), College of American Pathologists (CAP)

7.Monitor, report and make recommendations for improvement to NDRI Quality management trends, non-conformances/deviations via the Problem Management System, Quality System Reviews, operationally-related accidents/incidents (in coordination with HR), and customer complaints.

8. With Business Development, coordinate opportunities to ensure integration of implemented quality assurance practices.

9.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.

10.  Responsible for tissue source site qualification activities.

11.  Responsible for the review of equipment validation, including guidance to ensure the validation activities meet the requirements of NDRI’s Quality Manual and Quality Policy.

12.  Responsible for all Quality Assurance standards and final approval of NDRI policies and procedures.

13.  Maintain current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring.


Qualifications:

1.      Master's degree is required with 7-10 years of quality program management experience.

2.      Minimum 7-10 yrs. experience in Quality Systems Management Implementation, QA  Administration, and QA Audit process and in a medical research-related environment.

3.      Quality related certifications required: Certified Tissue Bank Specialist (AATB) and/or Certified Quality Auditor (ASQ)

4.      Demonstrated competency in computer skills: MS office applications, query tools, and enterprise database systems.

Self-motivated, able to accomplish multiple assignments simultaneously

 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 problem solving.

Advanced computer skills

Detail-orientated

Benefits:

Life insurance equal to two times your annual salary, up to $200,000 maximum

Long term disability insurance,

Participation in our insurance plan through IBXfor you and your eligible dependents, (including dental and eye coverage) (20% employee contribution)


20 Vacation days/year

11 Holidays,

10 Sick days,

2 Personal days/year,

Commuter Program

In addition, after completing one full year of employment and participation in the TIAA-CREF 403(b) retirement program, NDRI will contribute up to 4% of your salary in matching funds.

Salary:

$90k - 100k

Posting Expiration Date:

1/5/2020

How to Apply:

Qualified and Interested candidates should submit their resume through email at:

[email protected]


 

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