Quality Operations Leader (Remote) – DP & CMOs

TG Therapeutics, Inc.; Northern (KY); Hybrid; USD 140,000 - 200,000; Full time

Job summary

TG Therapeutics, Inc. is seeking a Senior Manager/Associate Director of Quality Operations to provide quality oversight across external drug product and finished product manufacturing networks. The role leads batch disposition, Quality decisions, and continuous improvement of TG's QMS.

The position requires strong cross-functional leadership, extensive GMP/biologics experience, and proficiency with Veeva. Remote work with occasional site engagement is expected.

Qualifications

• Minimum 7 years of GMP Quality and/or biologics manufacturing experience.
• Experience independently overseeing CMOs and GMP suppliers; driving supplier performance.
• Thorough knowledge of applicable cGMP regulations and Quality Systems requirements.
• Experience with batch disposition, deviations, investigations, CAPAs, change controls, risk management and validation.
• Experience supporting technology transfer, process validation/PPQ, and manufacturing readiness preferred.
• Proficiency with electronic QMS platforms such as Veeva.
• Strong written and verbal communication, critical thinking and decision-making skills.
• Ability to lead cross-functional activities and influence without direct authority.

Responsibilities

• Provide Quality oversight of external DP and finished product manufacturing networks, including CMOs and GMP suppliers.
• Lead batch disposition and ensure compliance with cGMPs and TG procedures.
• Review and approve deviations, investigations, CAPAs, change controls, and risk assessments.
• Oversee technology transfers, process validation/PPQ, and supplier governance.
• Support regulatory inspections and inspection readiness with internal and external partners.
• Maintain Quality metrics, supplier performance, and QMS improvements.

Skills

GMP quality

Biologics manufacturing

Cross-functional leadership

Regulatory readiness

Technical writing

Decision making

Education

University degree in life sciences or related field

Post-graduate education preferred

Tools

Veeva

Job description

TG Therapeutics, Inc. is seeking a Senior Manager/Associate Director of Quality Operations to provide quality oversight across external drug product and finished product manufacturing networks. The role leads batch disposition, Quality decisions, and continuous improvement of TG's QMS.

The position requires strong cross-functional leadership, extensive GMP/biologics experience, and proficiency with Veeva. Remote work with occasional site engagement is expected.