Director, Central Quality Audit, Pharmacovigilance

🔥 17 hours ago

🇺🇸 United States – Remote

💵 $142.4k - $213.6k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• 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

• 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

• 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