Senior Manager​/Assoc. Director, Quality Operations

Title:
Senior Manager/Associate Director, Quality Operations

Location:
Remote

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.

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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 expand significant product, compliance, or supply risks as appropriate.

The Sr. Manager/Associate Director also provides Quality oversight of technical transfers, process validation/PPQ, supplier governance, inspection readiness, and continuous improvement of TG’s Quality Management System (QMS). The role requires proactive ownership, strong cross‑functional leadership, sound judgment, attention to detail, and the ability to operate independently with minimal management oversight.

The position may be filled at the Senior Manager or Associate Director level based on the candidate’s experience, technical expertise, and demonstrated ability to independently lead external manufacturing Quality activities. The Sr. Manager/Associate Director, Quality Operations reports directly to the Senior Director, Quality Operations.

• Serve as the primary Quality lead for assigned drug product and finished product CMOs, CTLs, and GMP suppliers, providing proactive oversight of manufacturing, testing, packaging, release, and lifecycle activities.
• Independently assess complex Quality and manufacturing issues; establish clear, risk-based Quality positions; drive timely issue resolution; and expand significant product, compliance, or supply risks as appropriate.
• Lead batch disposition for DP and finished product in accordance with cGMPs, TG procedures, Quality Agreements, validated processes, and applicable regulatory submissions.
• Review, assess, and approve deviations, investigations, CAPAs, change controls, risk assessments, and other GMP records; ensure conclusions are scientifically sound, complete, accurate, and supported by documented evidence.
• Provide Quality leadership for technology transfers, process validation/PPQ, and manufacturing readiness, including review and approval of technology transfer protocols, master batch records, validation strategies/protocols/reports and associated risk assessments.
• Review and approve controlled…