Quality Operations Leader — Senior Manager/Associate Director

TG Therapeutics, Inc.; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

TG Therapeutics, Inc. is seeking a Sr.

Manager/Associate Director of Quality Operations to lead external manufacturing quality activities across drug product, finished product, and device processes, ensuring regulatory compliance and product quality. You will oversee CMOs, manage batch disposition, deviations, CAPAs, and risk management, and partner with Technical Operations, Regulatory Affairs, and Supply Chain to support lifecycle and Veeva QMS workflows.

Qualifications

• 7+ years in GMP Quality and/or biologics manufacturing.
• Experience supporting commercial manufacturing and lifecycle management.
• Strong knowledge of cGMP requirements and quality decision making.
• Experience overseeing CMOs and quality governance.

Responsibilities

• Serve as primary quality lead for drug product and device manufacturing partners.
• Lead batch disposition and ensure adherence to cGMPs and quality agreements.
• Review deviations, investigations, CAPAs, change controls, and risk assessments.
• Provide oversight of technology transfer, process validation, and manufacturing readiness.
• Develop and maintain Quality Agreements with CMOs and GMP partners.
• Support regulatory inspections and supplier qualification processes.

Skills

GMP Quality

Biologics manufacturing

Quality oversight

Risk management

Education

Life sciences degree

Tools

Veeva

Job description

TG Therapeutics, Inc. is seeking a Sr.

Manager/Associate Director of Quality Operations to lead external manufacturing quality activities across drug product, finished product, and device processes, ensuring regulatory compliance and product quality. You will oversee CMOs, manage batch disposition, deviations, CAPAs, and risk management, and partner with Technical Operations, Regulatory Affairs, and Supply Chain to support lifecycle and Veeva QMS workflows.