Senior Clinical Quality Assurance Manager
AbbVie Inc.
Lead clinical quality assurance for AbbVie’s global Affiliate research, applying quality systems and regulatory expertise to support clinical development. Travel across AREA may reach 35% as needed.As Senior Manager, you will provide proactive quality management across designated countries and regions within AbbVie’s RDQA AREA organization. The work supports clinical research, quality excellence, regulatory preparedness, and first pass approvals. You will oversee compliance, risk management, audits, inspections, and quality strategy while collaborating with clinical development leaders, Affiliates, and RDQA functions.Key Responsibilities:
Drive proactive quality management across designated countries and regionsDevelop risk identification, mitigation, and control strategiesOversee quality governance, compliance, and regulatory preparednessSupport health authority inspections, audits, and supplier qualificationsMentor AREA managers, associates, and line managementRequirements:
Bachelor’s degree in medical science or equivalent technical experienceEight-plus years in biopharmaceutical, medical device, or related functionsThree years leading people, initiatives, or projectsThorough knowledge of quality systems and auditing standardsStrong regulatory, analytical, communication, and influencing skillsBring clinical research quality, audit leadership, and regulatory expertise to AbbVie’s Affiliate operations across the AREA region.
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Drive proactive quality management across designated countries and regionsDevelop risk identification, mitigation, and control strategiesOversee quality governance, compliance, and regulatory preparednessSupport health authority inspections, audits, and supplier qualificationsMentor AREA managers, associates, and line managementRequirements:
Bachelor’s degree in medical science or equivalent technical experienceEight-plus years in biopharmaceutical, medical device, or related functionsThree years leading people, initiatives, or projectsThorough knowledge of quality systems and auditing standardsStrong regulatory, analytical, communication, and influencing skillsBring clinical research quality, audit leadership, and regulatory expertise to AbbVie’s Affiliate operations across the AREA region.
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