Global Quality Assurance Auditor, Pharmacovigilance

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $102.3k - $153.5k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

🏥 Healthcare

🏢 Enterprise

💰 $1.2G Post IPO secondary on 2024-12

Healthcare • Enterprise

GE HealthCare is a global healthcare technology company focused on developing products, technologies, and solutions that improve patient care and healthcare delivery. The company emphasizes innovation, next-generation solutions, and improving wellbeing worldwide. It operates in many countries (offices in 80 countries) and offers career opportunities across early careers and professional roles. GE HealthCare communicates a mission to make healthcare better and champions employee wellbeing, diversity, and equal opportunity.

📋 Description

• Plan, prepare, and execute internal and external audits for QRA • Ensure audit actions and observations appropriately remediate deficiencies and are completed on time • Review completed actions for effectiveness • Undertake risk analysis of systems and processes with customers • Propose process and functional audits • Support regulatory inspections and customer audits as a functional QA subject matter expert • Conduct trend analysis of audit and other quality-related data • Provide audit and quality data analyses to internal and external stakeholders • Assure completion and documentation of vendor qualification and surveillance activities • Participate in quality management system improvements • Provide guidance on CAPAs, including risk assessment, corrective and preventive actions, and required evidence • Perform QA approvals of Quality Event records • Monitor MHRA, FDA, EMEA, and other regulatory guidelines and legislation • Support updates to operating procedures, risk assessments, and change controls • Inform the company of relevant regulatory changes • Provide Quality Assurance support, guidance, and management of assigned Quality Issues • Share insights and industry trends to support continued 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 • Demonstrated experience applying classic Quality tools • Demonstrated 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 • Willingness to complete a drug screen, as applicable

🏖️ 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 • Competitive compensation • Performance-based incentive compensation, which may include cash bonuses and/or long-term incentives (LTI)

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