Assoc. Dir​/Director, Program Management, QC Testing

Title:
Associate Director/Director - Program Management, QC Testing

Location:
Remote

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

Role

The Associate Director/Director Program Management, QC Testing is responsible for managing outsourced analytical and quality control testing activities performed by Contract Development and Manufacturing Organizations (CDMOs), and external testing laboratories. This role serves as the primary business and operational liaison between the company and external testing partners, ensuring timely delivery of quality testing data to support product development, clinical manufacturing, regulatory submissions, and commercial supply.

The successful candidate will coordinate testing activities, manage supplier performance, oversee project timelines, mitigate risks, and ensure compliance with GMP, GLP, ICH, FDA, EMA, and other applicable regulatory requirements.

• Serve as the primary relationship manager for external laboratories, CMOs, CDMOs, and contract testing vendors.
• Establish and maintain productive partnerships with testing organizations.
• Monitor supplier performance against quality, delivery, cost, and compliance metrics.
• Lead regular business reviews with testing partners.
• Collaborate with Quality Assurance to manage supplier qualification and ongoing oversight activities.
• Lead contract negotiations, Statements of Work (SOWs), change orders and budget management.

• Develop and manage project plans for analytical testing activities supporting development, clinical, and commercial programs.
• Coordinate timelines for method transfers
• Track project milestones and ensure testing deliverables are completed on schedule.
• Facilitate cross-functional communication among Technical Development, Manufacturing, Regulatory Affairs, Quality, Supply Chain, and external testing partners.
• Maintain project dashboards and status reports for management reviews.
• Manage multiple testing vendors simultaneously in a fast-paced environment.

• Track testing expenditures and project budgets.
• Forecast testing resource requirements and laboratory capacity needs.
• Identify opportunities for cost optimization while maintaining quality and compliance.
• Support annual planning and budgeting activities for outsourced analytical services.

• 12+ years of experience in biotechnology, pharmaceutical, or life sciences industries.
• 3+ years of supplier management, external manufacturing, or outsourced testing oversight experience.
• Experience managing CDMOs, and contract testing laboratories.
• Strong understanding of QC testing within biologics, cell therapy, gene therapy, vaccines, and/or pharmaceutical products.
• Experience supporting clinical and/or commercial product development programs.

• Knowledge of GMP and GLP regulations.
• Understanding of analytical methods commonly used in biotechnology, including but not limited to:
  • Potency assays
  • Compendial Methods
  • Cell-based assays
  • HPLC/UPLC
  • Mass spectrometry
  • PCR/qPCR
  • Flow cytometry
  • Bioburden and microbial testing
  • Endotoxin testing
  • Stability testing
• Familiarity with method validation and technology transfer processes.
• Working knowledge of ICH, USP, EP, FDA, and EMA expectations.

• PMP (Project Management Professional)
• ASQ Certified Quality Engineer (CQE)
• ASQ Certified Quality Auditor (CQA)
• Lean Six Sigma Certification

• Bachelor's degree in Biology, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline required.
• Advanced degree (MS, PhD, MBA) 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…