Director, Central Quality Audit, Pharmacovigilance

🕒 August 4

🇺🇸 United States – Remote

💵 $142.4k - $213.6k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 21%

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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 • Ensure alignment with regulatory expectations and industry best practices • 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 across the organization • Interpret internal and external business challenges and recommend best practices to improve products, processes, or services • Stay informed of industry trends that may influence the work

🎯 Requirements

• 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 cGMP, GDP, GPvP, GCP and GLP • 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 • Must successfully complete a drug screen, as applicable • Experience with Medical Device QMS requirements and FDA CFR 21 820 and ISO 13485 is desired • Prior 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 using Six Sigma and DFR tools • Demonstrated ability to analyze and resolve problems • Exceptional conflict-resolution skills • Ability to interface with top organizational leadership and internal and external customers • Demonstrated ability to lead programs/projects and prioritize and drive multiple programs • Integrity and adherence to high ethical, moral, and personal values

🏖️ Benefits

• 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 • Performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)