In Vitro Diagnostics Precision Medicine Quality Senior Manager

Location: Remote
Compensation: Salary
Staff Reviewed: Wed, Feb 07, 2024
This job expires in: 14 days

Job Summary

A company is looking for an In Vitro Diagnostics Precision Medicine Quality Senior Manager.

Key Responsibilities:
  • Develop collaborative partnerships with Research and Development (R&D) to establish the state of quality and potential areas of quality risk exposure
  • Support the implementation of IVD quality management strategies to ensure compliance to an evolving and complex IVD regulatory landscape
  • Provide risk-based quality assurance and oversight for IVD/Precision Medicine activities
Required Qualifications:
  • Doctorate degree and 2 years of quality management experience OR Master's degree and 6 years of quality management experience OR Bachelor's degree and 8 years of quality management experience OR Associate's degree and 10 years of quality management experience OR High school diploma / GED and 12 years of quality management experience
  • At least 3 years of experience in the pharmaceutical/biotech or medical device industry working within quality a quality management system role, or other relevant experience in clinical research that includes quality oversight
  • An understanding of medical device development and applicable Global Regulations
  • An understanding of Precision Medicine and applicable Global Regulations
  • An understanding of Quality Management Systems (QMS), including electronic QMS such as Veeva or TrackWise (Sparta Systems)

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