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)
