Job Description

AbbVie seeks a Quality Assurance Manager in Cincinnati to oversee quality compliance across pharmaceutical, device, and biologic manufacturing. The role combines strategic oversight of quality systems with direct staff leadership and regulatory liaison responsibilities.

Responsibilities

• Direct quality assurance activities from raw material inspection through final product shipment
• Hire, evaluate performance, and develop quality assurance staff members
• Lead compliance assessments, deviation investigations, and CAPA programs
• Interface with FDA and regulatory agencies during inspections and compliance matters
• Communicate quality metrics and compliance status to senior management

Requirements

• Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, or Engineering
• 8+ years quality assurance, quality oversight, or equivalent experience
• Leadership experience with technical professionals and cross-functional teams
• Knowledge of GMP compliance, FDA/EMA/ICH regulations, and QA systems
• Familiarity with pharmaceutical, biological, or device manufacturing processes
• Strong written and verbal communication skills across management levels

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