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Director, Quality Assurance

Company: NDRI - National Disease Research Interchange
Location: Philadelphia
Posted on: November 15, 2019

Job Description:

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 Functions
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 Quality Policy.
5. Design,interpret, and implement Quality Assurance systems and practices in accordancewith federal, state, and other regulations and requirements.
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 complaints.
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 effectivenessmonitoring.
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 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

    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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