Job Description Summary
Managing, ensuring and improving capabilities to comply with external standards and regulations. Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description
Roles and 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.
Required Qualifications
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.
Desired Characteristics
Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
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 15%.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
We will not sponsor individuals for employment visas, now or in the future, for this job opening.
Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. 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).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided:
No