Senior Quality Systems Lead — GMP, CAPA & eQMS

TG Therapeutics, Inc.

United States

On-site

USD 120,000 - 150,000

Full time

14 days+

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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.