Senior Manager, Quality Systems

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

Legitimate TG Therapeutics job offers will only come from individuals whose email addresses end in @tgtxinc.com. TG Therapeutics only uses LinkedIn and our TG corporate website for job postings. TG Therapeutics does not use Flock or any other social media platforms other than LinkedIn.

Organizational Overview:

TG Therapeutics is a fully-integrated, commercial-stage, biopharmaceutical 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 has received approval from the United States Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) in the US and European Commission.

Position:

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.

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, elevate 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.