In Vitro Diagnostics Precision Medicine Quality Senior Manager

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)