Job Summary

• Owns the configuration of the electronic Quality Management System module for audit records, executes User Assessment Testing (UAT), manages change management, and ensures system documentation is maintained.
• Executes against GEHC's Central Quality & Regulatory Audit program, including scheduling, preparation, execution, reporting, and follow-up activities, and supports GEHC Health / Competent Authority audits.
• Develops self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship, and collaborating with stakeholders to achieve desired results.

Matching Summary

Salary

Base: $142,400.00-$213,600.00 Annual; Bonus/Equity: Performance based incentive compensation; Benefits: Medical, dental, vision, paid time off, 401(k), life, disability, accident insurance, tuition reimbursement

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 progressive responsibility
• Direct experience configuring, managing, and qualifying an electronic Quality Management System
• Qualified Lead Auditor with active certification
• Minimum 5 years experience driving Global programs
• Experience with Pharmaceutical QMS and regulatory requirements
• Experience with Medical Device QMS and regulatory requirements

Work Rights