Senior Quality Systems Lead — GMP, CAPA & eQMS

TG Therapeutics, Inc.; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

TG Therapeutics, Inc. is seeking a Senior Manager, Quality Systems to own core GxP processes, act as SME for deviations, CAPA, change control, and quality metrics, and drive inspection readiness in a virtual/outsourced model.

You will coordinate cross-functional quality deliverables and ensure alignment with FDA, ICH, EU/EMA expectations. The role requires strong GMP operations knowledge, hands-on eQMS experience (Veeva preferred), and the ability to lead with limited oversight while mentoring

Qualifications

• 5–10+ years in Quality Assurance, Quality Systems, or GxP compliance.
• Strong knowledge of FDA regulations, ICH guidelines, EU/EMA expectations, GxP requirements, data integrity.
• Experience with deviations, investigations, CAPA, change control, document control, training systems, supplier/vendor quality, audits, and management review metrics.
• Experience operating in a virtual, outsourced, or lean pharmaceutical company model (CMOs/CROs).
• Hands-on experience with electronic Quality Management Systems; Veeva Quality preferred.

Responsibilities

• Own and lead Quality Systems processes ensuring compliance and continuous improvement.
• Serve as SME for internal Quality Systems and provide risk-based guidance.
• Lead quality governance forums and review boards (deviations, CAPA, change control, metrics).
• Manage quality records lifecycle from initiation to closure and escalation of issues.
• Develop and optimize SOPs, templates, training materials, and workflows.

Skills

Quality systems knowledge

Cross-functional leadership

Data analysis

Technical writing

Project management

Education

Bachelor's degree in Pharmaceutical Sciences / Life Sciences / Chemistry / Biology / Engineering or related field

Tools

Veeva Quality

Power BI

Excel

Smartsheet

Job description

TG Therapeutics, Inc. is seeking a Senior Manager, Quality Systems to own core GxP processes, act as SME for deviations, CAPA, change control, and quality metrics, and drive inspection readiness in a virtual/outsourced model.

You will coordinate cross-functional quality deliverables and ensure alignment with FDA, ICH, EU/EMA expectations. The role requires strong GMP operations knowledge, hands-on eQMS experience (Veeva preferred), and the ability to lead with limited oversight while mentoring