Associate Director, Quality Operations

GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com.

GENERAL PURPOSE OF THE JOB:

Responsible for some of the daily operations of One Lab conducting the testing of clinical DNA specimens for the purpose of diagnosing genetic disease, using manual and automated methods in a team environment, and following established policies and procedures in a professional manner.

Essential Duties and Responsibilities include the following. Other duties may be assigned. 

1. Assumes some of the responsibilities of Supervisor (as defined by CLIA). Specific Supervisor responsibilities include:
   1. Directs day-to-day activities of the laboratory operation and staff.
   2. Is accessible at all times on site, by telephone or by electronic consultation, to resolve technical problems in accordance with policies and procedures established by the Director of Operations.
   3. In the absence of the Director of Operations, monitors the performance characteristics of the test and ensures that acceptable levels of performance are maintained based on established quality controls, indicators, and procedures. Documents and reports performance issues or trends promptly to the Director of Operations and Lab Director, if necessary, ensuring regulatory compliance. Uses appropriate resources to troubleshoot and address quality issues and implements corrective and preventive action, including tools such as retraining, additional control checks, etc.
   4. May fully assume those responsibilities of the Director of Operations that are permitted to be delegated, which are limited to (i) takes necessary remedial action when test performance characteristics deviate from established standards, (ii) prevents test results from being reported when a test is not functioning correctly, (iii) provides orientation and training to testing personnel, and (iv) annually evaluates and documents the performance of all testing personnel.
2. Assists with the hiring and onboarding of lab personnel.
3. Maintains sufficient familiarity with OneLab assays, including NextGen Sequencing, Array, PCR-based techniques, and extraction in order to effectively direct processes.
4. Monitors and recommends improvements to procedures and lab processes.
5. Performs other related duties as assigned including but not limited to amending SOPs, revising lab protocols, overseeing validations and implementation of new tests and new lab procedures.

Supervisory Responsibilities

This position may manage subordinate supervisors who supervise employees in their respective group. Is responsible for the overall direction, coordination, and evaluation of these units. Also may directly supervise non-supervisory employees. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Competencies

Mathematical, computer, reasoning, and language skills at the professional level.

Pay Transparency, Budgeted Range$116,000—$153,000 USD

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Science - Minded, Patient - Focused. 

At GeneDx, we create, follow, and are informed by cutting-edge science. With over 20 years of expertise in diagnosing rare disorders and diseases, and pioneering work in the identification of new disease-causing genes, our commitment to genetic disease detection, discovery, and diagnosis is based on sound science and is focused on enhancing patient care.

Experts in what matters most. 

With hundreds of genetic counselors, MD/PhD scientists, and clinical and molecular genomics specialists on staff, we are the industry’s genetic testing experts and proud of it. We share the sam