Teams at Terrestrial Bio, Inc.

Supports quality assurance for combination medical products, focusing on device design controls, risk management, cGMP compliance, process validation, supplier quality, and batch record review. Maintains QMS documentation, DHFs, risk analyses, SOPs, protocols, and reports; participates in MRB, CAPA, deviations, audits, and regulatory inspection readiness. Collaborates with Manufacturing, Process Development, Quality Control, and Material Management during early clinical development.

Leads the Process Analytical Technology function for a microneedle array patch manufacturing program. Owns PAT strategy, technology evaluation, method development and validation, chemometric modeling, control strategy, SPC integration, data infrastructure, and transition to real-time release testing. Partners with manufacturing, process development, and formulation teams; supports regulatory submissions and inspections; oversees CSV and data integrity under GAMP 5; and builds the PAT organization toward commercialization.

Provides hands-on QA oversight for GMP manufacturing, packaging, QC testing, materials, equipment, and facilities. Reviews batch records, analytical data, protocols, and reports for accuracy, data integrity, and compliance. Supports inspections, deviations, OOS/OOT investigations, CAPA, change controls, validation activities, batch disposition, material inspection, equipment qualification, and facility readiness. Collaborates cross-functionally to resolve quality issues and maintain inspection readiness in a combination product environment.