Director of Quality Oversight

4 days ago


Cambridge, Massachusetts, United States Jobot Full time

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

Responsibilities:
  • Provide quality support and guidance for our CMC programs
  • Plan, conduct or facilitate supplier qualification audits and site visits for GMP suppliers
  • Provide quality oversight GMP suppliers
  • Extensive document review and approval for: master batch records, executed batch documentation, analytical test methods, specifications, stability protocols and reports, release testing COAs and reports, etc.
  • Review and support GMP investigations associated with lot-related deviations, change controls, CAPAs, OOS/OOT investigations
  • Perform lot disposition
  • Ensure that GMP quality documentation is securely archived and retrievable
  • Investigate, evaluate, and manage potential quality impact of product complaints and temperature excursions
  • Contribute to the development of our QMS as needed
  • Ensure inspection readiness at our GMP suppliers
  • Provide GMP quality review and feedback on regulatory application submissions and agency responses/information requests
  • Continuous improvement of quality and compliance practices to ensure highest standards are maintained

$220,000 - $260,000 per year



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