DEEPLY COMMITTED TO PATIENTS

Title: Senior Manager, Quality Systems

Location: Remote

If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.

Organizational Overview

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by several foreign nations for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.TGTherapeutics.com.

Role

The Senior Manager, Quality Systems reports to Quality Systems/Quality Operations leadership and is responsible for the ownership, execution, and continuous improvement of core GxP Quality Management System processes within a virtual and outsourced pharmaceutical operating model. This role serves as a subject matter expert for key Quality Systems, including deviations, investigations, CAPA, change control, quality metrics, and inspection readiness. This individual will coordinate quality-related projects across functions, oversee data and document management within electronic systems, and ensure alignment of quality deliverables across internal stakeholders. The position provides hands-on execution, cross-functional leadership, and risk-based Quality System oversight to ensure internal processes remain compliant, effective, scalable, and aligned with applicable FDA, ICH, EU/EMA, and global regulatory expectations.

The ideal candidate combines a strong understanding of GMP operations with expertise in quality systems, process optimization, and GxP compliance.

 

Key Responsibilities

• Own and lead assigned Quality Systems processes and programs, ensuring effective execution, compliance, performance monitoring, inspection readiness, and continuous improvement.
• Serve as a functional subject matter expert for internal Quality Systems and provide practical, risk-based guidance to internal stakeholders.
• Lead or participate in Quality governance forums, including deviation/CAPA review boards, change control review meetings, quality metric reviews, supplier performance reviews, and inspection readiness meetings.
• Oversee quality record lifecycle activities, including initiation, triage, investigation, root cause analysis, risk assessment, approval, closure, effectiveness checks, and escalation of significant quality issues.
• Design, revise, and optimize SOPs, work instructions, templates, job aids, workflows, and training materials to support consistent, compliant, and scalable Quality System execution.
• Serve as a business process owner or functional SME for electronic Quality Systems, including Veeva Quality or comparable eQMS and document management platforms.
• Develop, analyze, and present Quality System metrics, KPIs, dashboards, backlog reports, and trend analyses to support management review, governance, risk escalation, and continuous improvement. Coordinate quality deliverables across internal stakeholders to ensure timely completion of milestones
• Identify systemic quality trends, recurring issues, process gaps, data integrity concerns, and compliance risks; recommend appropriate corrective, preventive, or escalation actions.
• Partner cross-functionally with Quality, Regulatory, Clinical, Technical Operations, Supply Chain, Pharmacovigilance, IT, and CSV to ensure internal Quality Systems are practical, risk-based, compliant, and business-aligned.
• Support vendor, CMO, and CRO oversight by ensuring quality events, supplier issues, quality agreements, audit findings, and change notifications are evaluated, documented, trended, and escalated appropriately.
• Support inspection readiness by ensuring Quality System records, metrics, procedures, training, and governance documentation are complete, accurate, current, and audit-ready.
• Train, mentor, and coach internal staff or cross-functional users on Quality System expectations, eQMS use, good documentation practices, root cause analysis, CAPA effectiveness, and sustainable compliance.

Support implementation and lifecycle management of new QMS system modules and workflows by participating in user acceptance testing (UAT) and contributing ideas for QMS system process improvements.

 

Professional Experience/Qualifications

• 5–10+ years of progressive experience in Quality Assurance, Quality Systems, or GxP compliance within the pharmaceutical, biotechnology, biologics, medical device, or similarly regulated industry.
• Strong knowledge of FDA regulations, ICH guidelines, EU/EMA expectations, GxP requirements, data integrity principles, and global regulatory expectations applicable to pharmaceutical Quality Systems.
• Demonstrated experience supporting or owning deviations, investigations, root cause analysis, 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 involving CMOs, CROs, external laboratories, consultants, and third-party service providers.
• Hands-on experience with electronic Quality Management Systems and document/training platforms; Veeva Quality, preferred.
• Demonstrated ability to analyze quality data, identify systemic trends, escalate risk, and present actionable insights to leadership and cross-functional stakeholders.
• Strong technical writing skills, including experience drafting or revising SOPs, controlled documents, quality reports, inspection responses, training materials, and governance documentation.
• Strong communication, stakeholder management, cross-functional leadership, and influencing skills, including the ability to lead initiatives without direct authority.
• Ability to manage competing priorities, mentor others, operate independently, and make sound, risk-based decisions with minimal oversight.
• Experience with Power BI, Excel, Smartsheet, Veeva reports/dashboards, or similar tools used to create trackers, metrics, and leadership-ready quality performance reporting preferred.

 

Education

• Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Chemistry, Biology, Engineering, or related scientific discipline required; advanced degree preferred.

 

Applicants must be currently authorized to work in the United States on a full-time basis. The company does not sponsor employment visas for this position.

TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.