- Develop and manage quality documentation, including SOPs and training materials.
- Co-host and lead customer audits.
- Participate in regulatory inspections.
- Perform process, project, vendor, and investigator site audits.
- Conduct quality control reviews of regulatory documents.
- Lead quality issue, deviation investigation, and CAPA closures.
- Manage training curricula and learning management system administration.
- Support quality metrics, RFI, and vendor questionnaires.