Director, Central Quality Audit - Remote

Overview

The Director of Central Quality Audit is responsible for managing and improving compliance with external standards and regulations within the medical technology and pharmaceutical industries.

In Short

• Manage the electronic Quality Management System for audit records.
• Execute User Assessment Testing (UAT) and manage change management.
• Oversee GEHC's Central Quality & Regulatory Audit program.
• Prepare and manage internal audits, reporting compliance concerns.
• Define and maintain metrics for Quality & Regulatory issues.
• Lead functional teams and projects with indirect resources.
• Provide mentorship and training on Quality & Regulatory practices.
• Communicate complex concepts and influence management decisions.
• Travel globally up to 40% for audits and meetings.
• Foster a culture of integrity and compliance within the organization.

Requirements

• Master’s Degree with 5 years or Bachelor’s Degree with 10 years in medical device/pharmaceutical industry.
• Direct experience with electronic Quality Management Systems.
• Qualified Lead Auditor certification.
• Experience with cGMP, GDP, GPvP, GCP, GLP.
• Familiarity with FDA CFR 21 820 and ISO 13485.
• Prior experience with Veeva and TrackWise Digital is a plus.
• Strong problem-solving and conflict-resolution skills.
• Exceptional communication skills in English.
• Ability to lead and prioritize multiple programs.
• Integrity and adherence to high ethical standards.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive benefits package including medical, dental, and vision.
• 401(k) plan with employee and company contributions.
• Paid time off and tuition reimbursement.
• Professional development opportunities.
• Supportive work environment that fosters collaboration.
• Challenging career paths in healthcare innovation.
• Commitment to diversity and equal opportunity.
• Relocation assistance not provided.
• Employment conditioned upon successful completion of a drug screen.