Senior Manager Aseptic Product Quality

📋 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 relevant Life Science or other technical required. Graduate degree desired.
• Technical or Analytical background required for problem resolution with technical, quality, product
• Total combined experience of minimum 10+ years in Quality Assurance Operations, Regulatory
• Regulatory inspection experience with direct interaction with regulatory inspectors required.
• Direct Plant experience in a pharmaceutical setting with a minimum of 5 years preferred.
• Knowledge and comprehensive understanding of some biological and/or pharmaceutical technologies

🎁 Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)