Job Summary

• Owns the configuration of the electronic Quality Management System module for audit records.
• Executes against GEHC's Central Quality & Regulatory Audit program, including scheduling, preparation, execution, reporting, and follow-up activities.
• Regularly advises management in Central Quality, requiring specialized depth and/or breadth of expertise within a quality or regulatory discipline.

Matching Summary

Salary

$142,400.00-$213,600.00 Annual; Performance based incentive compensation; Competitive benefits package

Skills & Requirements

Key Requirements

• Master’s Degree and 5 years' experience OR Bachelor's Degree and 10 years' experience OR High School Diploma and 15 years' experience in medical device/pharmaceutical industry
• Direct experience configuring, managing, and qualifying an electronic Quality Management System
• Qualified Lead Auditor with active certification
• Minimum of 5 years’ experience driving Global programs
• Experience with Pharmaceutical QMS and regulatory requirements (cGMP, GDP, GPvP, GCP, GLP)
• Experience with Medical Device QMS and regulatory requirements (FDA CFR 21 820, ISO 13485)

Work Rights