Director of Quality

The Director of Quality provides strategic and operational leadership for the Good Manufacturing Practice quality function supporting the development, manufacture, testing, and release of Phase I biologics clinical trial materials. The role is accountable for establishing, maintaining, and continuously improving a phase-appropriate GMP Quality Management System for early clinical biologics manufacturing. This position ensures that investigational biologics are manufactured, tested, documented, stored, and released in accordance with applicable GMP requirements and regulatory filings.