Clinical Research Quality Compliance Leader
AbbVie Inc.
Shape quality compliance for AbbVie clinical research through auditing, risk mitigation, and inspection readiness across designated Affiliates and regions. The position requires travel up to 35%.This Senior Manager role sits within AbbVie’s independent RDQA AREA organization, supporting clinical development and research activities worldwide. You will strengthen the One AbbVie Quality System, assess compliance, identify root causes, and guide corrective action. Collaboration with RDQA teams, clinical development leaders, Affiliate management, suppliers, and health authorities is central to the work.Key Responsibilities:
Conduct audits against regulations, guidelines, policies, and requirementsCommunicate audit results and approve corrective action plansDevelop inspection strategies with AREA leadership and functionsProvide inspection responses and participate in health authority inspectionsEstablish quality measures and drive regional quality strategyRequirements:
Bachelor’s degree in Biology, Nursing, Pharmacy, or related scienceEight-plus years of relevant industry quality or development experienceLeadership experience involving people, initiatives, or projectsUnderstanding of local and global regulatory requirementsExcellent written, oral, presentation, and negotiation skillsApply quality systems, clinical research auditing, and inspection expertise to advance AbbVie’s regulatory readiness and development goals.
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Conduct audits against regulations, guidelines, policies, and requirementsCommunicate audit results and approve corrective action plansDevelop inspection strategies with AREA leadership and functionsProvide inspection responses and participate in health authority inspectionsEstablish quality measures and drive regional quality strategyRequirements:
Bachelor’s degree in Biology, Nursing, Pharmacy, or related scienceEight-plus years of relevant industry quality or development experienceLeadership experience involving people, initiatives, or projectsUnderstanding of local and global regulatory requirementsExcellent written, oral, presentation, and negotiation skillsApply quality systems, clinical research auditing, and inspection expertise to advance AbbVie’s regulatory readiness and development goals.
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Vacancy posted 1 hour ago
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