GMP Quality Oversight Specialist

4 days ago


Cambridge, Massachusetts, United States Jobot Full time

Join Jobot, a dynamic biotechnology company dedicated to developing cutting-edge treatments for chronic dermatological diseases. As a Senior Director, Quality Assurance, you will play a pivotal role in ensuring the highest quality standards across our clinical development programs and manufacturing processes.

About the Role
  • Foster a culture of quality excellence by providing guidance and support for our CMC programs.
  • Oversight GMP suppliers to ensure timely delivery of high-quality materials and services.
  • Maintain accurate and up-to-date records of GMP quality documentation, promoting transparency and accountability.
Key Responsibilities:
  • Conduct thorough investigations into potential quality impacts of product complaints and temperature excursions.
  • Develop and implement strategies to maintain inspection readiness at our GMP suppliers.
  • Collaborate with cross-functional teams to review and provide GMP quality feedback on regulatory application submissions and agency responses/information requests.
Requirements:
  • Advanced degree in a scientific field or related discipline.
  • At least 10 years of experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting.
  • Demonstrated expertise in supporting early phase clinical through commercial manufacturing, including contract manufacturers.
Work Environment:

This hybrid role demands 3 days on-site, with an estimated 10-20% travel required (domestic and international).

Salary:

$145,000 - $175,000 per year, reflecting your exceptional skills and experience.



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