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Quality Systems Manager

AbbVie · North Chicago, IL

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Role summary

AbbVie seeks a Quality Systems Manager to oversee quality assurance across pharmaceutical, device, and biologic manufacturing operations. The role involves regulatory compliance, supplier management, cross-functional coordination, and implementation of quality systems and training programs.

What they're looking for

  • Bachelor's degree in chemistry, pharmacy, biology, microbiology, engineering, or related technical/scientific field
  • 8+ years quality assurance, quality oversight, or equivalent experience
  • Leadership experience with technical professionals and cross-functional teams
  • Knowledge of GMP compliance, regulatory requirements for devices, biologics, and pharmaceuticals
  • Technical expertise in quality, regulatory affairs, process sciences, or manufacturing operations
  • Strong written and oral communication skills at all management levels
  • Demonstrated ability to lead medium to large projects of increasing complexity

What you'll be doing

  • Ensure quality regulation compliance for drug, biologic, device, and combination products
  • Lead project teams in planning and approval of quality documentation and system changes
  • Design and maintain effective quality systems, procedures, and processes across functions
  • Coordinate with cross-functional teams including R&D, supply chain, regulatory, and commercial groups
  • Support new product introductions and design changes while performing compliance assessments

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