GE HealthCare is hiring a Director, Central Quality Audit

GE HealthCare Careers is seeking a Director, Central Quality Audit to lead our compliance and audit capabilities. In this role, you will interpret business challenges and recommend best practices to improve products and processes while executing and supporting our Central Quality & Regulatory Audit program and Quality Management System.

What You'll Do

• Own the configuration of the electronic Quality Management System module for audit records.
• Execute User Assessment Testing (UAT), manage change management, and ensure system documentation is maintained.
• Execute GEHC's Central Quality & Regulatory Audit program, including scheduling, preparation, execution, reporting, and follow-up activities.
• Identify and communicate high-risk issues, report compliance concerns, and recommend improvements to business leadership.
• Ensure audit strategy is executed to current industry practices and regulatory expectations.
• Support GEHC Health/Competent Authority audits, including preparation, back-room management, tracking Lessons Learned, and driving follow-up activities.
• Support GEHC Quality Management System by defining, tracking, and maintaining metrics to promote early awareness of Quality & Regulatory issues.
• Regularly advise management in Central Quality.
• Lead functional teams or projects with indirect resources and medium to high risk/complexity.
• Develop self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship.

What We're Looking For

• A Master’s Degree and a minimum of 5 years’ experience in medical device and/or pharmaceutical industry; or a Bachelor's Degree and a minimum of 10 years’ experience; or a High School Diploma and a minimum of 15 years' of progressive responsibility in the 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 directly driving Global programs to resolve quality compliance issues.
• 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.

Nice to Have

• Prior Veeva and TrackWise Digital experience.
• Prior health authority experience.
• IRCA, ASQ (CQE, CQA, etc.) and/or Lean Certification (green belt, black belt).
• Extensive experience in the Medical Device and Pharmaceutical industry.
• Understanding of product quality improvement using tools such as Six Sigma, DFR.
• Demonstrated ability to analyze and resolve problems.
• Exceptional conflict-resolution skills.
• Ability to interface with top organizational leadership and internal and external customers.
• Demonstrated ability to lead programs/projects and prioritize multiple programs.
• Ability to energize others through personal involvement, trust, feedback, coaching, and accountability.
• Strong oral and written communication skills in English.
• High integrity and adherence to ethical, moral, and personal values.
• Ability to travel globally up to 40%.

Team & Environment

You will lead functional teams or projects with indirect resources.

Benefits & Compensation

• Medical, dental, vision insurance
• Paid time off
• 401(k) plan with employee and company contribution opportunities
• Life, disability, and accident insurance
• Tuition reimbursement
• Performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)
• Compensation: $139,200.00-$208,800.00 Annual

Work Mode

This is a global role.

GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.