Krystal Biotech Benefits Overview

Support QA for gene therapy GMP manufacturing: produce and review GMP documentation, maintain quality systems, update SOPs, support FDA audit readiness, and ensure regulatory compliance for cGxP operations.

Coordinate end-to-end finished-product logistics for temperature-controlled pharmaceutical shipments, managing cold chain and specialty couriers, preparing global export documentation, liaising with 3PLs, resolving logistics exceptions, supporting GMP/GDP compliance, monitoring serialization alerts, and tracking performance and invoices.

Support clinical operations by managing clinical supplies, ensuring protocol and regulatory compliance, training and monitoring investigative sites per GCP/ICH, assisting with budgets/invoices, maintaining TMF documentation, reviewing site SOPs, and performing site visits (qualification, initiation, monitoring, closeout). Travel up to 50% during peak periods.