Global Quality Assurance Auditor, Pharmacovigilance

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $102.3k - $153.5k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 analyses of systems and processes and propose process/functional audits • Support regulatory inspections and customer audits as a functional QA subject matter expert • Conduct trend analysis of audit and quality-related data for internal and external stakeholders • Assure completion and documentation of vendor qualification and surveillance activities • Participate in quality management system improvements • Guide CAPA setup and perform QA approvals of Quality Event records • Monitor MHRA, FDA, EMEA, and other regulatory guidelines and legislation; implement and communicate relevant changes • Provide QA support, guidance, and management of assigned Quality Issues • Proactively share industry trends and insights 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 experience in the pharmaceutical industry • 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 • Experience in collaboration, negotiation, and conflict resolution • Knowledge of GPvP, cGMP, and GDP • Strong oral and written communication skills • Ability to analyze and resolve problems • Ability to document, plan, market, and execute programs • Established project management skills • Experience applying classic Quality tools • Effective interpersonal, teamwork, and networking skills • Ability to influence and argue a position effectively within the business context • Legally authorized to work in the United States; employment visa sponsorship is not provided • Successful completion of a drug screen, as applicable

🏖️ Benefits

• Medical, dental, and vision insurance • Paid time off • 401(k) plan with employee and company contribution opportunities • Life, disability, and accident insurance • Tuition reimbursement • Professional development • Challenging careers • Competitive compensation • Performance-based incentive compensation, which may include cash bonuses and/or long-term incentives (LTI)