- Implement and maintain quality systems in alignment with regulatory requirements like FDA, ICH, 21 CFR Part 11, and ISO 9001.
- Manage, mentor, and support a high-performing quality team.
- Serve as primary administrator for the electronic Quality Management System (eQMS).
- Direct core QMS processes including document control, training, risk management, audits, CAPA, and supplier management.
- Provide quality oversight for clinical study development and operations to ensure GCP compliance.
- Review and approve software development deliverables and maintain SDLC processes for in-house software.
- Analyze quality metrics to identify trends, risks, and implement systemic improvements.
Project ManagementGCP