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AbbViePosted 3 weeks ago

Aseptic Product Quality Associate Director

$141,500–$268,500 year

HybridNorth Chicago, Illinois, United States

Full TimeSenior LevelEnterprise

Job Summary

Lead the Aseptic External & Product Quality Assurance Eye Care Global Team by developing and implementing aseptic strategies that ensure robust product quality assurance. Conduct due diligence visits to prospective external partners (TPMs/CMOs) and perform hands-on assessments of aseptic manufacturing operations, processes, and controls. Provide technical quality leadership for aseptic-related investigations, including root cause identification, risk evaluation, and the development of corrective and preventive actions. Monitor emerging technologies, regulatory expectations, and industry trends while delivering strategic input to support risk-based decision-making. Build collaborative relationships with internal manufacturing sites and global aseptic teams to foster a culture centered on proactive risk management and operational excellence. This role requires a minimum of 10 years in Quality Assurance Operations Management with direct regulatory inspection experience and direct plant experience preferred.

Required Qualifications

  • Bachelor's Degree in relevant Life Science or other technical
  • Technical or Analytical background
  • Minimum of 10+ years in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting
  • Required regulatory inspection experience with direct interaction with regulatory inspectors
  • Direct Plant experience in a pharmaceutical setting with a minimum of 5 years
  • Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background
  • Experience working the requirements for third party external manufacturing

Desired Qualifications

  • Graduate degree
  • Direct Plant experience in a pharmaceutical setting with a minimum of 5 years preferred

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