Note: The job is a remote job and is open to candidates in USA. TG Therapeutics is a commercial-stage biopharmaceutical company focused on developing and commercializing treatments for B-cell diseases. The Senior Manager/Associate Director, Quality Operations provides Quality oversight of external drug product and finished product manufacturing networks, leads batch disposition and Quality decision-making, and oversees suppliers, technology transfers, validation, inspections, and Quality Management System improvements.
Responsibilities
- Serve as the primary Quality lead for assigned drug product and finished product CMOs, CTLs, and GMP suppliers, providing proactive oversight of manufacturing, testing, 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 and finished product in accordance with cGMPs, TG procedures, Quality Agreements, validated processes, and applicable regulatory submissions
- Review, assess, and approve deviations, investigations, CAPAs, change controls, risk assessments, and other GMP records; ensure conclusions are scientifically sound, complete, accurate, and supported by documented evidence
- 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%
Skills
- • 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 and drug product manufacturing, with experience supporting commercial manufacturing and lifecycle management; clinical-stage experience is also valued
- • Thorough working knowledge of applicable cGMP regulations and Quality Systems requirements, with the ability to apply requirements to complex manufacturing 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, risk management, and validation activities is required
- • 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
- • University degree in life sciences or related fields is required
- •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
- • Experience supporting technology transfer, process validation/PPQ, and manufacturing readiness is strongly preferred
- • Direct interaction with FDA, EMA, or other regulatory agencies during regulatory inspections is preferred
- • Experience interacting with EMA Qualified Persons (QPs) is preferred
- • Post-Graduate education is preferred
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