Quality Operations Leader (Remote) – DP & CMOs

TG Therapeutics, Inc.; United States; Hybrid; USD 140,000 - 200,000; Full time

Job summary

TG Therapeutics, Inc. is seeking a Senior Manager/Associate Director of Quality Operations to provide quality oversight across external drug product and finished product manufacturing networks. The role leads batch disposition, Quality decisions, and continuous improvement of TG's QMS.

The position requires strong cross-functional leadership, extensive GMP/biologics experience, and proficiency with Veeva. Remote work with occasional site engagement is expected.

Qualifications

• Minimum 7 years of GMP Quality and/or biologics manufacturing experience.
• Experience independently overseeing CMOs and GMP suppliers; driving supplier performance.
• Thorough knowledge of applicable cGMP regulations and Quality Systems requirements.
• Experience with batch disposition, deviations, investigations, CAPAs, change controls, risk management and validation.
• Experience supporting technology transfer, process validation/PPQ, and manufacturing readiness preferred.
• Proficiency with electronic QMS platforms such as Veeva.
• Strong written and verbal communication, critical thinking and decision-making skills.
• Ability to lead cross-functional activities and influence without direct authority.

Responsibilities

• Provide Quality oversight of external DP and finished product manufacturing networks, including CMOs and GMP suppliers.
• Lead batch disposition and ensure compliance with cGMPs and TG procedures.
• Review and approve deviations, investigations, CAPAs, change controls, and risk assessments.
• Oversee technology transfers, process validation/PPQ, and supplier governance.
• Support regulatory inspections and inspection readiness with internal and external partners.
• Maintain Quality metrics, supplier performance, and QMS improvements.

Skills

GMP quality

Biologics manufacturing

Cross-functional leadership

Regulatory readiness

Technical writing

Decision making

Education

University degree in life sciences or related field

Post-graduate education preferred

Tools

Veeva

Job description

Title: Senior Manager/Associate Director, Quality Operations

Location: Remote

If you are interested in the below position, please send your resume to [e-mail] 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 Sr. Manager/Associate Director of Quality Operations provides Quality oversight of TG Therapeutics’ external drug product (DP), finished product, and combination product manufacturing network across clinical and commercial manufacturing, aseptic fill finish, visual inspection, packaging and labeling, device assembly, technology transfer, validation/PPQ, and lifecycle activities. This role serves as the primary Quality point of contact for assigned Contract Manufacturing Organizations (CMOs), combination product/device manufacturing partners, and other GMP suppliers, ensuring product quality, regulatory compliance, supplier performance, and timely issue resolution.

This position leads Quality decision making and batch disposition activities for drug product (DP), finished product, and combination product operations. The role is expected to evaluate complex manufacturing, device, and compliance issues, develop clear and scientifically sound Quality positions, apply risk based decision making, communicate decisions effectively to internal and external stakeholders, and escalate significant risks appropriately.

The Sr. Manager/Associate Director also provides Quality oversight of technical transfers, process validation/PPQ, combination product risk management, supplier governance, inspection readiness, and continuous improvement of TG’s Quality Management System (QMS). The role requires proactive ownership, strong cross functional leadership, sound judgment, attention to detail, and the ability to operate independently.

The position may be filled at the Senior Manager or Associate Director level based on the candidate’s experience, technical expertise, and demonstrated ability to independently lead external manufacturing Quality activities. The Sr. Manager/Associate Director, Quality Operations reports directly to the Senior Director, Quality Operations.

Key Responsibilities

• Serve as the primary Quality lead for assigned drug product, finished product, and combination product CMOs, CTLs, device manufacturing partners, and GMP suppliers, providing proactive oversight of manufacturing, testing, device assembly, packaging, release, and lifecycle activities.
• Independently assess complex Quality and manufacturing issues; establish clear, risk-based Quality positions; drive timely issue resolution; and escalate significant product, compliance, or supply risks as appropriate.
• Lead batch disposition for DP, finished product, and combination product in accordance with cGMPs, TG procedures, Quality Agreements, validated processes, and applicable regulatory submissions.
• Review, assess, and approve deviations, investigations, CAPAs, change controls, and risk assessments for drug product and combination product activities; ensure conclusions are scientifically sound, complete, accurate, and supported by documented evidence.
• Provide Quality oversight for combination product lifecycle activities, including device assembly, control strategy, design transfer, manufacturing readiness, validation, complaint and failure investigation support, and management of changes that may affect product performance, safety, or regulatory commitments.
• Lead or support combination product risk management activities throughout the product lifecycle, including review and maintenance of risk management plans and files, risk analyses, hazard evaluations, risk controls, residual risk assessments, and linkage of manufacturing and postmarket quality signals to product risk management, as applicable.
• Provide Quality leadership for technology transfers, process validation/PPQ, and manufacturing readiness, including review and approval of technology transfer protocols, master batch records, validation strategies/protocols/reports and associated risk assessments.
• Review and approve controlled manufacturing and testing documentation for commercial programs, including master batch records, protocols, specifications, and final reports.
• Drive supplier Quality governance through routine performance reviews, Quality metrics/KPIs, issue escalation, action tracking, and follow-up to ensure commitments and timelines are met.
• Develop, negotiate, implement, and maintain Quality Agreements with CMOs and other GMP partners; ensure responsibilities remain aligned with current operations and regulatory expectations.
• Conduct or support supplier qualification and Quality audits and ensure appropriate follow-up and closure of observations and commitments.
• Support regulatory inspections, customer audits, and inspection-readiness activities for TG and external manufacturing partners, including on-site representation as needed.
• Partner cross-functionally with Technical Operations, Supply Chain, Regulatory Affairs, and other functions to support product supply, lifecycle management, and business objectives while maintaining Quality and compliance requirements.
• Provide clear, concise, accurate, and audience-appropriate written and verbal communications of Quality assessments, decisions, risks, and required actions to internal and external stakeholders.
• Contribute to continuous improvement of TG Quality Operations and the QMS, including process mapping, SOP development/revision, implementation of improvements, and effectiveness monitoring.
• Maintain, review, and trend Quality metrics and supplier performance indicators; use data to identify risks, recurring issues, and opportunities for improvement.
• Maintain complete and accurate tracking tools and Quality records; leverage approved precedent records, procedures, electronic systems, and available productivity tools to support efficient and consistent execution.
• Travel to CMOs, suppliers, and TG offices as necessary to support business and compliance needs, approximately 15%.

Professional Experience/Qualifications

• Minimum 7 years of progressive experience in GMP Quality and/or biologics manufacturing; experience commensurate with Associate Director-level responsibilities is required.
• Demonstrated knowledge of biologics, drug product, and combination product manufacturing, with experience supporting commercial manufacturing and lifecycle management; clinical stage experience is also valued.
• Thorough working knowledge of applicable cGMP and combination product Quality requirements, including 21 CFR Parts 210/211 and 21 CFR Part 4, with the ability to apply requirements to complex manufacturing, device, and Quality decisions.
• Demonstrated experience independently overseeing CMOs and/or other GMP suppliers and driving supplier performance, issue resolution, and Quality governance.
• Experience with batch disposition/release, deviations/investigations, CAPAs, change controls, Quality risk management, and validation activities is required; experience applying risk management principles to combination products is strongly preferred.
• Experience supporting technology transfer, process validation/PPQ, and manufacturing readiness is strongly preferred.
• Proficiency with electronic QMS platforms such as Veeva and comfort using digital collaboration, documentation, and productivity tools is required.
• Strong critical thinking, technical writing, problem-solving, and decision-making skills, with the ability to independently develop and defend Quality positions.
• Excellent organization, time management, follow-through, and attention to detail, with the ability to manage multiple priorities and deadlines.
• Strong written and verbal communication skills, including the ability to communicate complex Quality matters clearly to technical, business, and external audiences.
• Demonstrated ability to lead cross-functional activities, influence without direct authority, and build effective relationships with internal stakeholders and external partners.
• Experience providing Quality oversight for combination products, including device constituent parts, device assembly, design transfer, risk management, and lifecycle changes, is strongly preferred.
• Direct experience with autoinjector or similar drug delivery device development, manufacturing, validation, and commercial readiness is preferred.
• Experience supporting a successful FDA filing and approval of an autoinjector combination product is highly preferred.
• Direct interaction with FDA, EMA, or other regulatory agencies during regulatory inspections is preferred.
• Experience interacting with EMA Qualified Persons (QPs) is preferred.

Education

University degree in life sciences or related fields is required. Post-Graduate education is 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.