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Quality Systems Manager

AbbVie

AbbVie seeks a Manager Quality Systems to provide quality assurance oversight for pharmaceutical, biological, device, and combination products. The role involves supplier management, regulatory compliance, cross-functional project leadership, and implementing quality systems across manufacturing operations.

Responsibilities

  • Ensure quality regulations compliance for drugs, biologics, cosmetics, devices, and combination products
  • Lead project teams in planning and approval of quality documentation and system procedures
  • Manage supplier qualification, approval, risk management, and governance activities
  • Coordinate quality system elements, training, and continuous improvement across functions and facilities
  • Support new product introduction and design changes; prepare data for regulatory and internal audits

Requirements

  • Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or related scientific field
  • 8+ years quality assurance, quality oversight, or equivalent professional experience
  • Leadership experience with technical professionals and cross-functional teams
  • Knowledge of GMP compliance, regulatory requirements for devices, biologics, and pharmaceuticals
  • Familiarity with pharmaceutical, biological, or device product manufacturing
  • Strong oral and written communication skills at all management levels
  • Ability to manage medium to large projects independently and with guidance
Vacancy posted 7 days ago
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