The Director, Central Quality Audit at GE HealthCare will lead the global Pharmacovigilance (PV) Audit Program, ensuring compliance with regulatory standards and driving continuous improvement across PV operations. This role involves strategic leadership, audit execution, regulatory inspection readiness, and team development within a global medical technology environment.
What You'll Do
- 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.
- Identify high-risk compliance issues, escalate findings, and provide actionable recommendations to senior leadership.
- Prepare for and support PV-related health authority inspections, including back-room management and post-inspection follow-up.
- Define and track PV audit KPIs, ensuring visibility of compliance risks and trends to leadership.
- Manage audit-related modules within the electronic Quality Management System (eQMS), including support of configuration, UAT, and documentation.
- Lead and develop a team of 3–5 auditors, providing coaching, mentorship, and performance management.
- Partner with PV Operations, Quality, and Regulatory teams to ensure audit outcomes drive continuous improvement.
- Contribute to policy development and influence PV compliance strategy across the organization.
What We're Looking For
- 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.
Nice to Have
- 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%.
Technical Stack
- Veeva
- TrackWise Digital
- electronic Quality Management System (eQMS)
Team & Environment
- Team of auditors focused on Pharmacovigilance (PV) audits
- Team size: 3–5
- Culture: Act with humility and build trust, Lead with transparency, Deliver with focus, Drive ownership, Unyielding integrity, Every voice makes a difference, Every difference builds a healthier world, Fosters care, collaboration and support
Benefits & Compensation
- Salary range: $142,400.00 - $213,600.00 Annual
- Performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)
- Competitive benefits package including medical, dental, vision
- Paid time off
- 401(k) plan with employee and company contribution opportunities
- Life, disability, and accident insurance
- Tuition reimbursement
- Professional development
- Challenging careers
- Career opportunities in a culture that fosters care, collaboration and support
- Great work environment
Work Mode
- Location: United States
- Ability to travel globally up to 30%
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. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
