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GE HealthCare · 1 week ago

Director, Central Quality Audit

United States

Full-time

Remote

Lead/Staff, Director/Executive

$139K/yr - $209K/yr

5+ years exp

GE Healthcare is a leading global medical technology and digital solutions innovator. The Director of Central Quality Audit will manage and improve capabilities to comply with external standards and regulations, oversee audit operations, and lead a team of auditors while ensuring alignment with regulatory expectations and industry best practices.

AppsHealth CareHealth DiagnosticsHome ImprovementHome RenovationInternetMedical

Growth Opportunities

No H1B

Responsibilities

Own the Pharmacovigilance (PV) Audit Program: Develop, implement, and maintain the global PV audit strategy, ensuring alignment with regulatory expectations (e.g., EMA, FDA, MHRA, PMDA) and industry best practices

Manage Audit Operations: Oversee scheduling, planning, execution, reporting, and follow-up for PV audits, including internal audits and audits of service providers and affiliates. Fully participate in the audit program; actively owning and executing PV audits

Risk Identification and Communication: Identify high-risk compliance issues, escalate findings, and provide actionable recommendations to senior leadership

Regulatory Inspection Support: Prepare for and support PV-related health authority inspections, including back-room management and post-inspection follow-up

Metrics and Reporting: Define and track PV audit KPIs, ensuring visibility of compliance risks and trends to leadership

System Ownership: Manage audit-related modules within the electronic Quality Management System (eQMS), including support of configuration, UAT, and documentation

Team Leadership: Lead and develop a team of 3–5 auditors, providing coaching, mentorship, and performance management

Cross-Functional Collaboration: Partner with PV Operations, Quality, and Regulatory teams to ensure audit outcomes drive continuous improvement

Strategic Influence: Contribute to policy development and influence PV compliance strategy across the organization

Qualification

Lead Auditor certificationPharmacovigilance experiencePharmaceutical QMS knowledgeMedical Device QMS knowledgeRegulatory compliance experienceVeeva experienceTrackWise Digital experienceTeam leadership experienceSix Sigma knowledgeConflict-resolution skillsCommunication skillsProblem-solving ability

Required

Minimum 5 years of people leadership experience, including team development and performance management

Qualified Lead Auditor with active certification

Master's degree and 5+ years in pharmacovigilance or pharmaceutical industry; or Bachelor's degree and 10+ years relevant experience

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

Preferred

Prior Veeva and TrackWise Digital experience a plus

Prior health authority experience a plus

IRCA, ASQ (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt)

Extensive experience in the Medica 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, responding in a professional manner

Demonstrated ability to lead programs / projects. Ability to prioritize and drive multiple programs

Ability to energize others by building a connection with the team through personal involvement and trust, providing feedback and coaching to develop others, and accountability of actions

Strong oral and written communication skills in English

Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others

Ability to travel globally up to 30%

Benefits

Medical

Dental

Vision

Paid time off

A 401(k) plan with employee and company contribution opportunities

Life

Disability

Accident insurance

Tuition reimbursement

Company

GE HealthCare

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GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Founded in 1892

Chicago, Illinois, USA

10001+ employees