Quality Assurance Director Lead

19 hours ago


Cambridge, Massachusetts, United States Jobot Full time

Jobot is a publicly traded biotechnology company developing innovative solutions to treat chronic dermatological diseases. We are seeking an experienced Senior Director, Quality Assurance to provide quality oversight of our clinical development programs and manufacturing.

About the Role
  • Provide quality support and guidance for our CMC programs, ensuring seamless execution and compliance with regulatory requirements.
  • Oversight GMP suppliers to guarantee high-quality materials and services.
  • Ensure secure archival and retrieval of GMP quality documentation, maintaining transparency and accountability.
Responsibilities:
  • Investigate potential quality impact of product complaints and temperature excursions, implementing corrective actions as needed.
  • Ensure inspection readiness at our GMP suppliers, fostering strong relationships and open communication.
  • Review and provide GMP quality feedback on regulatory application submissions and agency responses/information requests.
Requirements:
  • Bachelor's degree in a scientific field or related discipline.
  • 10+ years' experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting.
  • Experience supporting early phase clinical through commercial manufacturing, including contract manufacturers.
Work Environment:

This hybrid position requires 3 days on-site, with approximately 10-20% travel expected (domestic and international).

Compensation:

$145,000 - $175,000 per year, offering a competitive salary package.



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