Senior Manager, Quality Systems

Legitimate TG Therapeutics job offers will only come from individuals whose email addresses end in @tgtxinc.com. TG Therapeutics only uses LinkedIn and our TG corporate website for job postings. TG Therapeutics does not use Flock or any other social media platforms other than LinkedIn.

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 Senior Manager, Quality Systems reports to Quality Systems leadership and is responsible for the ownership, execution, and continuous improvement of CAPA, effectiveness check, and supplier corrective action request (SCAR) processes within Veeva. Operating within a virtual and outsourced pharmaceutical model, this role serves as the process owner and subject-matter expert for these workflows, oversees record quality and timely progression, leads process governance and reporting, and supports the coordination of internal audits and external supplier audit activities. The position provides hands-on execution, cross-functional activities, and risk-based oversight to ensure records, audit support, and follow-up actions remain compliant, effective, inspection-ready, and aligned with applicable GMP and global regulatory expectations.

The ideal candidate combines strong GMP knowledge with hands-on Veeva expertise, disciplined quality-record management, data-driven process oversight, experience coordinating supplier audits in a virtual-company environment, and the ability to run reports, create monthly metrics, and identify risks and trends.

Key Responsibilities:

• Serve as the Veeva process owner and subject-matter expert for CAPAs, effectiveness checks, and supplier corrective action requests (SCARs).
• Manage quality records throughout their lifecycle, ensuring they are complete, work with SME to ensure accuracy, records are progressed in a timely manner, and written to meet GMP and good documentation practice requirements.
• Act as the primary point of contact for process questions and user support related to CAPAs, effectiveness checks, and SCARs.
• Generate, analyze, and present Veeva reports and dashboards to assess process health, including overdue records, record aging, extension volume, completion trends, and other key indicators.
• Proactively monitor open records, follow up with owners, resolve or escalate issues, and drive timely completion and closure.
• Lead weekly governance meetings to review record status, address issues, assign follow-up actions, escalate risks, and maintain accountability for commitments.
• Identify recurring issues, process gaps, data-quality concerns, and compliance risks; recommend and implement appropriate corrective, preventive, or process-improvement actions for system improvements and health.
• Develop, revise, and optimize SOPs, work instructions, templates, job aids, workflows, and training materials supporting CAPAs, effectiveness checks, SCARs, and related Veeva processes.
• Train and support record owners and cross-functional users on Veeva workflows, GMP documentation expectations, root cause analysis, action development, trending and effectiveness-check requirements.
• Support audit management and audit team lead with internal audits, external supplier audit management, and in person regulatory audits by gathering evidence, coordinating subject-matter experts, tracking observations, and supporting timely responses and follow-up actions as needed.
• AS needed, support the planning, scheduling, and coordinating of audits of TG external suppliers.
• Partner cross-functionally with Quality Operations, Technical Operations, Supply Chain, Regulatory, Clinical Quality, Pharmacovigilance, IT, CSV, and supplier stakeholders to ensure quality-system for owned processes are practical, risk-based, compliant, and business-aligned.
• Support implementation and lifecycle management of Veeva modules and workflows through user acceptance testing, issue identification, user support, and process-improvement recommendations.

Qualifications:

• 5–10+ years of progressive experience in Quality Assurance, Quality Systems, supplier quality, or GxP compliance within the pharmaceutical, biotechnology, biologics, medical device, or similarly regulated industry.
• Strong knowledge of GMP requirements, FDA regulations, ICH guidelines, EU/EMA expectations, good documentation practices, data integrity principles, and global regulatory expectations applicable to pharmaceutical Quality Systems.
• Demonstrated experience owning or administering CAPA, effectiveness-check, and SCAR processes, including record review, action development, due-date management, extensions, escalation, closure, and effectiveness verification.
• Hands-on experience with Veeva Quality is required , including workflow support, record lifecycle management, user support, and report or dashboard generation.
• Experience developing and analyzing process-health metrics such as overdue records, aging, extension volume, completion trends, and other quality performance indicators.
• Demonstrated ability to lead governance meetings, establish accountability, follow up with record owners, remove barriers, and escalate compliance or delivery risks appropriately.
• Experience supporting internal, supplier, and regulatory audits through evidence collection, subject-matter expert coordination, observation tracking, response support, and follow-up through closure.
• Experience planning and coordinating external supplier audits, including working with qualified third-party auditors and managing audit documentation, findings, responses, and closure activities.
• Experience operating in a virtual, outsourced, or lean pharmaceutical company model involving external suppliers, CMOs, CROs, laboratories, consultants, and third-party service providers.
• Strong technical writing and record-review skills, with the ability to assess documents for completeness, accuracy, clarity, GMP compliance, and inspection readiness.
• Strong communication, stakeholder-management, cross-functional leadership, and influencing skills, including the ability to lead initiatives and drive accountability without direct authority.
• Ability to manage competing priorities, operate independently, and make sound, risk-based decisions with minimal oversight.
• Experience with Excel, Power BI, Smartsheet, or similar tools used to create trackers, metrics, and leadership-ready quality performance reporting is a plus.

Education:

• Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Chemistry, Biology, Engineering, or related scientific discipline required; advanced degree 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.