- Oversee all aspects of drug manufacture and testing through clinical development and into commercial phase.
- Provide Quality oversight for analytical method development, qualification, validation, transfer, release testing, and stability programs.
- Support establishment of phase-appropriate specifications, stability-indicating methods, and control strategies.
- Review and approve validation protocols, raw data, and reports for test method, process, and cleaning.
- Manage the batch release program by reviewing executed documentation, raw data, quality events, and product disposition decisions.
- Lead or support quality event resolution investigations, ensuring root cause analysis, CAPA development, and timely closure.
- Maintain effective communication with CDMOs and CTLs to ensure Quality objectives are achieved.
Quality Assurance