Associate Director, Aseptic Product Quality

Added
14 days ago
Type
Full time
Salary
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Related skills

quality assurance pharmaceuticals gmp root cause analysis regulatory compliance

📋 Description

  • Lead the Aseptic External & Product Quality Assurance Eye Care Global Team by developing and
  • Conduct due diligence visits to prospective external partners (TPMs/CMOs) as a member of
  • Perform hands-on assessments of aseptic manufacturing operations, processes, and controls, while
  • Provide technical quality leadership for aseptic-related investigations, including root cause
  • Monitor and evaluate emerging technologies, regulatory expectations, and industry trends related to
  • Provide quality oversight of external manufacturing operations to ensure compliance with applicable

🎯 Requirements

  • Bachelor’s degree in a relevant Life Science or other technical discipline required. Technical or
  • Total combined years of experience: minimum of 10+ years in Quality Assurance Operations
  • Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies
  • Possesses the knowledge and skill set to operate within an environment that requires a high degree
  • Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or
  • A wide range of activities is undertaken, from long-term strategy development to short-term crisis
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