About this opportunity
TG Therapeutics, Inc. lists this Director/Sr. Director, R&D Quality opportunity in morrisville, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Title: Director/Senior Director, R&D Quality
Location: Remote (with periodic visits to TG headquarters in Morrisville, NC)
If you are interested in the below position, please send your resume and REFERENCE THE POSITION TITLE within the subject line.
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 U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit
Role
The Director of R&D Quality will lead TG Therapeutics’ R&D Quality team and provide independent oversight of Good Clinical Practices (GCP) activities to ensure compliance with FDA, EMA, ICH, other applicable global and national regulatory requirements across TG’s clinical programs.
This role reports directly to the Chief Quality Officer, with a dotted line to Head of Clinical Operations. This role will provide leadership to integrate and coordinate activities in alignment with other departments and company goals. He/she will manage personnel and projects based on short-term and long-term objectives.
Key Responsibilities
Strategic Leadership and Oversight
Develop and implement mid- and long-term R&D Quality plans, in collaboration with Clinical Operations, Clinical Development, Drug Safety/Pharmacovigilance, Regulatory Affairs, etc.
Build, lead, and mentor a high-performing R&D Quality team.
Align quality initiatives with TG’s business and development priorities.
Audits, Inspections, and Supplier Oversight
Lead quality oversight of GCP/GCLP suppliers, including qualification/requalification, annual reviews, and audits.
Design and manage TG’s annual clinical site audit program.
Design and lead the execution of GCP inspection readiness projects and related activities at TG.
Host/co-host all GCP regulatory inspections and external audits of TG and its partners.
Lead/co-lead inspection readiness activities at clinical sites, and all GCP/GCLP suppliers.
Quality Systems & Compliance
Ensure delivery of all clinical QA outputs, including authoring/review/approval of deviations, CAPAs, SCARs, continuous improvements, and other quality records.
Author, review, and implement SOPs, work instructions, and controlled documents.
Perform QA review and/or approval of clinical study documents, cross-functional SOPs, and other controlled documents.
Drive risk assessments, gap analyses, and continuous improvement initiatives.
Technical Expertise & Training
Act as a subject matter expert for GCP interpretation, applying regulatory guidance, industry best practice, and TG SOPs.
Train and mentor TG staff on global GCP regulations and inspection readiness.
Contribute to building and evolving TG’s GxP Quality culture.
Professional Experience/Qualifications
Experience
15+ years of GCP-related experience in clinical QA, clinical development lifecycle oversight, clinical study monitoring, or vendor management.
5+ years of direct clinical QA leadership and supervisory experience.
Experience in preparing for, participating in, or hosting FDA BIMO or other global GCP inspections strongly preferred.
Expertise
In-depth knowledge of global GCP regulations, ICH guidelines, and regulatory inspection practices.
Experience with electronic quality systems (e.g., Veeva Quality Vault) strongly preferred.
Strong leadership, organizational, and project management skills with ability to prioritize in a fast-paced environment.
Skills
Excellent written and verbal communication for internal and external interactions.
Deep understanding and experience in adopting a risk-based approach for problem-solving, root cause analysis, and strategic thinking balanced with attention to detail.
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.
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Worksite address
morrisville, NC, 27560, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.