Director of Quality Excellence

3 weeks ago


Cambridge, Massachusetts, United States Jobot Full time

We are a publicly traded biotechnology company developing innovative biologics to address chronic dermatological diseases.

The estimated salary for this position is approximately $175,000 per year, considering the industry standard and location. The role requires an expert in biologics, specifically operational QA experience with monoclonal antibodies, and a strong background partnering with external manufacturers.

This job involves providing quality support and guidance for our CMC programs, ensuring inspection readiness at GMP suppliers, and reviewing and approving quality documentation.

Key responsibilities include:

  • Providing quality oversight of clinical development programs and manufacturing
  • Reviewing and approving master batch records, executed batch documentation, analytical test methods, specifications, stability protocols and reports
  • Ensuring GMP quality documentation is securely archived and retrievable

This position also entails investigating potential quality impact of product complaints and temperature excursions, as well as providing quality review and feedback on regulatory application submissions and agency responses/information requests.



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