Director of Quality Assurance

6 days ago


South San Francisco, United States GQR Full time

The Director of Quality Assurance will be responsible for handling GMP Quality Operations for drug substance activities, managing CSPs, vendors and CMOs. This person will be building out a team of direct reports and will be playing a critical role as the company moves from late-clinical to commercialization.



Responsibilities:

  • Providing phase-appropriate oversight of internal and external QA operation activities
  • Oversight/management of manufacturing and quality control operations for programs in early and late stages
  • Handling Drug Substance oversight of contract service providers, including review of master/executed batch records, analytical test data, specifications
  • Review/Approve validation protocols/reports, analytical test methods, stability reports
  • Support QMS implementation, including vendor management, CAPAs/Deviations/Change Controls
  • Support Supplier Quality activities including audits
  • Contribute to CMC sections of submissions
  • Leadership responsibilities (cross-functional + building out a team)


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