TG Therapeutics, Inc.

Compensation

Full Description

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 Manager / Sr. Manager of R&D Quality will play a key role in supporting TG Therapeutics’ R&D Quality team by providing independent oversight of Good Clinical Practices (GCP) activities. This role ensures compliance with FDA, EMA, ICH, and other applicable global and national regulatory requirements across TG’s clinical programs. As an individual contributor, this role will work independently and collaboratively with cross-functional teams, serving as a Quality representative on study teams and inspection readiness initiatives. The role reports to the Director of R&D Quality. Key Responsibilities: Clinical Document and SOP Governance • Author, review, approve, and implement SOPs, work instructions, and other controlled documents owned by R&D Quality. • Perform QA review and/or approval of clinical study documents, SOPs, work instructions, and other controlled documents from Clinical Operations, Clinical Development, Regulatory Affairs, and other R&D functions. • Maintain quality documentation in alignment with regulatory expectations and TG procedures. Audits, Inspections, and Supplie Oversight • Manage audits of GCP/GCLP suppliers and clinical sites conducted by contract auditors. • Conduct or co-audit clinical site and GCP/GCLP supplier audits as needed. • Support internal audits of R&D processes, including hosting/conducting audits, reviewing/approving responses, and monitoring CAPA implementation. • Provide oversight of all GCP/GCLP suppliers, including supplier qualification/qualification, annual reviews, audits, QA led meetings and visits. • Support development of risk management processes, inspection readiness projects, and preparation for regulatory inspections of TG, clinical sites, and all GCP/GCLP suppliers. Quality Systems & Compliance • Own or manage Quality records related to GCP activities, e.g., deviations, CAPAs, SCARs, continuous improvements, audits, etc. • Prepare, analyze, and report on R&D quality metrics, issues, and progress to management. • Participate in configuration, testing, and validation activities for GCP systems. • Contribute to ongoing process improvements, risk assessments, and gap analyses to strengthen TG’s quality framework. Technical Expertise & Training • Provide GCP expertise to internal teams, clinical sites, and all GCP/GCLP suppliers to ensure compliant execution of activities. • Train and mentor TG staff on global GCP regulations, guidelines, and inspection readiness. • Represent R&D Quality at cross-functional team meetings, providing updates, escalation, and solutions to quality issues. Qualifications: Experience • 5+ years of GCP-related experience in clinical QA, clinical development oversight, clinical study monitoring, or vendor management. • 3+ years of direct clinical QA experience; inspection support experience strongly preferred. Expertise • Strong knowledge of GCP regulations, ICH guidelines, audits and regulatory inspection practices. • Experience with electronic quality systems (e.g., Veeva Quality Vault) strongly preferred. • Skilled at prioritizing in a dynamic environment with multiple competing timelines. Skills • Excellent oral and written communication with internal and external stakeholders. • Strong analytical and problem-solving ability, with experience applying risk-based approaches and root cause analysis. • Highly organized, detail-oriented, and proactive with a collaborative mindset, with a proactive, “can-do” approach. Education: • Bachelor’s degree in life sciences or a related field required. • Advanced degree (MS, PharmD, PhD) preferred. 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.