Quality Systems Leader — GxP, CAPA & Compliance

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

Job summary

TG Therapeutics, Inc. is seeking a Senior Manager, Quality Systems to own and drive core GxP Quality Management System processes across a virtual and outsourced operating model.

You will oversee deviations, investigations, CAPA, change control, metrics, and inspection readiness while coordinating quality delivery with multiple internal stakeholders. The ideal candidate brings 5–10+ years in QA/QMS within regulated pharma, deep knowledge of FDA/ICH/GxP, and hands-on experience with eQMS platforms

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Chemistry, Biology, Engineering, or related field.
• 5–10+ years of progressive experience in Quality Assurance, Quality Systems, or GxP compliance.
• Experience supporting deviations, investigations, CAPA, change control, documentation, audits, and management review metrics.
• Hands-on experience with electronic Quality Management Systems; Veeva Quality preferred.
• Strong technical writing and cross-functional collaboration.

Responsibilities

• Own and lead assigned Quality Systems processes and programs, ensuring effective execution, compliance, performance monitoring, inspection readiness, and continuous improvement.
• Provide practical, risk-based guidance to internal stakeholders as a SME for Quality Systems.
• Lead or participate in Quality governance forums (deviation/CAPA, change control, metrics, supplier performance, inspection readiness).
• Oversee quality record lifecycle activities from initiation to escalation of significant quality issues.
• Design and optimize SOPs, work instructions, templates, job aids, workflows, and training materials for scalable QMS execution.

Skills

GxP Compliance

Quality Systems

Deviations

CAPA

Change Control

Data Integrity

FDA Regulations

Quality Metrics

Quality Governance

Cross-functional Leadership

Education

Bachelor’s degree in Pharmaceutical Sciences or related field

Advanced degree preferred

Tools

Veeva Quality

Power BI

Excel

Smartsheet

eQMS

Job description

TG Therapeutics, Inc. is seeking a Senior Manager, Quality Systems to own and drive core GxP Quality Management System processes across a virtual and outsourced operating model.

You will oversee deviations, investigations, CAPA, change control, metrics, and inspection readiness while coordinating quality delivery with multiple internal stakeholders. The ideal candidate brings 5–10+ years in QA/QMS within regulated pharma, deep knowledge of FDA/ICH/GxP, and hands-on experience with eQMS platforms