Landmark Bio Benefits Overview

Leads the strategy, design, compliance, and continuous improvement of the Quality Management System for GMP biotech manufacturing operations. Owns documentation, training, deviations, CAPA, change control, supplier quality, risk management, audits, metrics, and management review. Builds and manages the Quality Systems team, leads audit readiness and responses, oversees supplier qualification, and partners cross-functionally to strengthen quality culture and compliance.

Perform hands-on GMP laboratory testing and method development for cell and gene therapy products. Develop, optimize, and qualify UHPLC and PCR-based assays; support method transfer, troubleshoot instruments and assays, maintain GMP documentation, and collaborate with development, manufacturing, and QA to ensure regulatory-compliant release and characterization testing.