Senior Manager/Assoc. Director, Quality Operations

Location: Remote

If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.

Organizational Overview

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by several foreign nations for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.TGTherapeutics.com.

Role

The Sr. Manager/Associate Director of Quality Operations provides Quality oversight of TG Therapeutics’ external drug product (DP) and finished product manufacturing network across commercial manufacturing, aseptic fill-finish, visual inspection, packaging and labeling, technology transfer, validation/PPQ, and lifecycle activities. This role serves as the primary Quality point of contact for assigned Contract Manufacturing Organizations (CMOs) and other GMP suppliers, ensuring product quality, regulatory compliance, supplier performance, and timely issue resolution.

This position leads Quality decision-making and batch disposition activities for drug product (DP) and secondary packaging operations. The role is expected to evaluate complex manufacturing and compliance issues, develop clear and scientifically sound Quality positions, communicate decisions effectively to internal and external stakeholders, and escalate significant risks appropriately.

The Sr. Manager/Associate Dir