Global Quality Assurance Auditor, Pharmacovigilance

🕒 June 18

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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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

• Provide QA auditing for the Pharmaceutical Diagnostics business, focusing on GMP manufacturing sites and Pharmacovigilance-related functions • Plan, prepare, and execute internal and external audits for QRA • Ensure audit actions and observations appropriately remediate deficiencies and are completed timely; review effectiveness • Work with customers to perform risk analysis of systems and processes and propose process or functional audits • Support regulatory inspections and customer audits as a functional QA subject matter expert • Conduct trend analysis of audit and quality-related data and provide findings to stakeholders • Assure completion and documentation of vendor qualification and surveillance activities • Participate in quality management system improvements • Provide guidance on CAPAs, including risk assessments, corrective and preventive actions, and supporting evidence • Perform QA approvals of Quality Event records • Monitor regulatory guidelines and legislation from MHRA, FDA, EMEA, and other regulatory bodies • Implement regulatory changes and inform the company of relevant updates • Provide QA support, guidance, and management of assigned Quality Issues • Proactively share industry insights and trends to support compliance and continuous improvement

🎯 Requirements

• Bachelor's degree from an accredited university or college, or a high school diploma/GED with at least 8 years of pharmaceutical industry experience • 6+ years of experience in the pharmaceutical industry • Previous auditing experience required • Experience interfacing with global regulatory agencies • Ability to comprehend and communicate key regulatory requirements and expectations • Knowledge of GPvP, cGMP, and GDP • Collaboration, negotiation, and conflict resolution skills • Strong oral and written communication skills • Demonstrated ability to analyze and resolve problems • Ability to document, plan, market, and execute programs • Established project management skills • Demonstrated experience applying classic Quality tools • Effective interpersonal, teamwork, and networking skills • Ability to influence and argue a position effectively within the business context

🏖️ Benefits

• Relocation Assistance Provided: No