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Project Manager, Compliance

Passionate about making a difference in the world of cancer genomics?

With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than ever before but providers don't have the infrastructure or expertise to make sense of this data. We're on a mission to connect an entire ecosystem to redefine how genomic data is used in clinical settings.

We are looking to add a Project Manager to join our Compliance team. This person will oversee, plan, coordinate, and manage quality assessment programs designed to ensure compliance with established standards of laboratory practice, CLIA, state regulations, CAP, and other specialty laboratory accrediting agencies.

What You’ll Do

  • Licensing and Accreditation: direct auditing process of the business unit, associated laboratories and specimen collection sites to ensure compliance with applicable federal, state, and local regulations.
  • Remain current with regulatory and compliance requirements.
  • Provide guidance to various functional groups and oversee progress through the project cycle.
  • Management of compliance related areas including implementation of procedures and processes.
  • Assist in addressing Legal and Compliance issues in conjunction with corporate departments.
  • Assist in the investigation of any reports or evidence of misconduct or non-compliance, and implementation of corrective action including training and retraining.
  • In coordination with management, ensure that departmental standard operating procedures and database are regularly updated to accurately reflect current processes.

Requirements

Education:

  • Bachelor’s degree (chemical, physical, biological or clinical laboratory science, or medical technology) required

Work Experience:

  • 3-5 years experience in a compliance setting environment required, laboratory experience highly preferred
  • Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirements required.

Competencies:

  • Strong interpersonal communication skills required
  • Demonstrated strong writing and composition skills required
  • Demonstrated success in motivating team members to reach desirable objectives
  • Understanding of clinical laboratory operations required
  • Ability to affect Quality Improvement through problem solving skills and knowledge of quality tools required
     
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