Quality Systems Leader: GxP Compliance & CAPA

TG Therapeutics, Inc.; United States; Remote; USD 120,000 - 190,000; Full time

Job summary

TG Therapeutics, Inc. is seeking a Senior Manager, Quality Systems to own and improve core GxP processes within a virtual and outsourced operating model. You will lead deviations, CAPA, change control, and quality metrics, ensuring inspection readiness and regulatory alignment.

The role requires 5–10+ years in quality assurance/compliance in pharma, strong data analysis, and hands-on QMS implementation using platforms like Veeva QMS; effective cross-functional leadership is essential.

Qualifications

• 5–10+ years in QA, Quality Systems, or GxP compliance.
• Strong knowledge of FDA, ICH, EU/EMA requirements.
• Experience with deviations, CAPA, investigations and change control.
• Hands-on with electronic QMS and document systems; Veeva preferred.
• Excellent communication and cross-functional leadership.

Responsibilities

• Own and lead Quality Systems processes, ensuring compliance and improvement.
• Serve as SME for internal Quality Systems and provide risk-based guidance.
• Lead governance forums: deviation/CAPA, change control, metrics reviews.
• Oversee quality record lifecycle from initiation to closure and escalation.
• Design and optimize SOPs, work instructions, templates, and training materials.
• Manage electronic Quality Systems platforms, including Veeva QMS.
• Develop and present Quality System metrics, KPIs, dashboards, and reports.
• Identify systemic trends and recommend corrective actions.
• Partner with Quality, Regulatory, Clinical, IT, and suppliers.
• Support vendor oversight and inspection readiness.
• Ensure audit-ready Quality System records and governance docs.
• Train and coach staff on QMS expectations and CAPA effectiveness.

Skills

Quality Systems

Deviations

CAPA

Change Control

eQMS

Veeva Quality

Data Analysis

Technical Writing

Stakeholder Mgmt

Leadership

Power BI

Excel

Education

Bachelor’s degree

Advanced degree preferred

Tools

Veeva QMS

Smartsheet

Job description

TG Therapeutics, Inc. is seeking a Senior Manager, Quality Systems to own and improve core GxP processes within a virtual and outsourced operating model. You will lead deviations, CAPA, change control, and quality metrics, ensuring inspection readiness and regulatory alignment.

The role requires 5–10+ years in quality assurance/compliance in pharma, strong data analysis, and hands-on QMS implementation using platforms like Veeva QMS; effective cross-functional leadership is essential.