Director, Central Quality Audit, Pharmacovigilance

GE HealthCare

GE HealthCare pharmacovigilance audit director owning global PV audit strategy and regulatory inspection support. Leading auditors and driving quality compliance improvements across medical technology and pharmaceutical operations.

Posted 8/4/2026full-timeRemote • 🇺🇸 United StatesLead💰 $142,400 - $213,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and implementing pharmacovigilance audit strategies, managing compliance risks, and leading audit teams. Proficient in regulatory requirements and quality management systems within the pharmaceutical and medical device industries.

Highest-signal resume keywords

Qualified Lead Auditor CertificationPharmacovigilance Audit Strategy DevelopmentPharmaceutical QMS RequirementsTeam Leadership and DevelopmentRegulatory Compliance Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmacovigilance AuditsQuality Management System (QMS)CGMPGDPGPvPGCPGLPSix SigmaDFRAudit KPI Tracking

Soft Skills

Conflict ResolutionProblem AnalysisCommunication Skills

Tools & Technologies

VeevaTrackWise Digital

Certifications & Qualifications

Qualified Lead AuditorIRCA CertificationASQ Certification (CQE, CQA, etc.)Lean Certification

Industry Keywords

Pharmaceutical IndustryMedical Device IndustryHealth Authority InspectionsCompliance StrategyQuality Compliance Issues

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develop, implement, and maintain the global pharmacovigilance audit strategy
Oversee scheduling, planning, execution, reporting, and follow-up for pharmacovigilance audits
Execute internal audits and audits of service providers and affiliates
Identify high-risk compliance issues, escalate findings, and provide actionable recommendations to senior leadership
Prepare for and support pharmacovigilance-related health authority inspections, including back-room management and post-inspection follow-up
Define and track pharmacovigilance audit KPIs and report compliance risks and trends to leadership
Manage audit-related modules within the electronic Quality Management System, including configuration support, UAT, and documentation
Lead and develop a team of 3–5 auditors through coaching, mentorship, and performance management
Partner with Pharmacovigilance Operations, Quality, and Regulatory teams to drive continuous improvement
Contribute to policy development and influence pharmacovigilance compliance strategy

Requirements

What you’ll need

Minimum 5 years of people leadership experience, including team development and performance management
Active Qualified Lead Auditor certification
Master’s degree and 5+ years in pharmacovigilance or the pharmaceutical industry, or Bachelor’s degree and 10+ years of relevant experience
Minimum 5 years’ experience directly driving global programs to resolve quality compliance issues
Experience with Pharmaceutical QMS requirements and cGMP, GDP, GPvP, GCP, and GLP regulatory requirements
Experience with Medical Device QMS requirements, FDA CFR 21 820, and ISO 13485 is desired
Veeva and TrackWise Digital experience is a plus
Prior health authority experience is a plus
IRCA, ASQ (CQE, CQA, etc.), and/or Lean Certification is a plus
Extensive experience in the medical device and pharmaceutical industry
Understanding of product quality improvement tools such as Six Sigma and DFR
Ability to analyze and resolve problems
Exceptional conflict-resolution skills
Ability to interface professionally with senior leadership and internal and external customers
Demonstrated ability to lead programs and projects
Ability to prioritize and drive multiple programs
Strong oral and written communication skills in English
Ability to travel globally up to 15%
Must be legally authorized to work in the United States; employment visa sponsorship is not available now or in the future
Successful completion of a drug screen, as applicable

Benefits

Comp & perks

Performance-based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)
Medical insurance
Dental insurance
Vision insurance
Paid time off
401(k) plan with employee and company contribution opportunities
Life insurance
Disability insurance
Accident insurance
Tuition reimbursement
Professional development
Challenging careers
Competitive compensation
Great work environment
Relocation assistance not provided