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
Scheduling, preparation, execution, reporting, and follow-up activities associated with Central Quality & Regulatory Internal Audits
Identification and communication of high-risk issues
Reporting compliance concerns and recommended improvements to business leadership
Ensuring audit strategy is executed to current industry practices and regulatory expectations
Supports GEHC Health / Competent Authority audits
Preparation, back-room management, tracking of Lessons Learned, and driving follow-up activities
Supports GEHC Quality Management System by defining, tracking, and maintaining metrics to promote early awareness and visibility of Quality & Regulatory issues
Regularly advises management in Central Quality

Master’s Degree and a minimum of 5 years’ experience in medical device and/or pharmaceutical industry; or Bachelor's Degree and a minimum of 10 years’ experience in medical device and/or pharmaceutical industry; or High School Diploma and a minimum of 15 years' of progressive responsibility in medical device and/or pharmaceutical industry
Direct experience configuring, managing, and qualifying an electronic Quality Management System for audit records
Qualified Lead Auditor with active certification
Minimum of 5 years’ experience driving Global programs to resolve quality compliance issues (directly)
Experience with Pharmaceutical QMS requirements and regulatory requirements including but not limited to cGMP, GDP, GPvP, GCP and GLP
Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485

Director, Central Quality Audit

Key skills