Director, Central Quality Audit, Pharmacovigilance

Job Description

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.

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, elevate 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.
• Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

Desired Characteristics

• 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%.

Benefits

Benefits include medical, dental, vision, paid time off, 401(k) plan with employee and company contribution opportunities, life, disability, accident insurance, and tuition reimbursement.

Compensation

Pay range: $142,400.00 – $213,600.00 per year. Eligible for performance‑based bonus and LTI.

Relocation Assistance

No relocation assistance provided.

Equal Employment Opportunity

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, 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).

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