Manager/Sr. Manager, Computer Systems Compliance

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Title: Manager/Senior Manager, Computer Systems Compliance Location: This is a hybrid/remote position, i.e. working remotely with periodic visits to TG’s NC office (Morrisville, NC) for meetings and collaborations with other teams. The preference is for East Coast (NYC, NJ, Boston, Philadelphia, Raleigh-Durham.) If you are interested in the below position, please send your resume to careers@tgtxinc.com

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 approval from the United States Food and Drug Administration (FDA) 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, in adults. TG has also received approval for BRIUMVI by the European Commission (EC) for the treatment of adult patients with RMS who have active disease defined by clinical or imaging features. TG Therapeutics has offices located in Morrisville, NC, New York City, and Edison, New Jersey. For more information, visit www.tgtherapeutics.com . Role

The Manager/Sr. Manager, Computer Systems Compliance is responsible for supporting computer system validation, IT Quality Assurance and Compliance. The role is responsible for writing and/or reviewing computer system validation documentation for assigned projects to ensure compliance with applicable process and regulatory requirements and for supporting other computer system compliance activities, such as change control and periodic reviews. Specific assignments and activities will vary based on the priorities, needs and project deliverables of the Quality team. This position reports to the Director, Computer Systems Compliance. Minimal travel to TG offices or suppliers is expected (10-15% of the time). – Write and/or review computer system validation documentation for process and regulatory compliance. – Lead risk assessments for new computer system implementation projects and change control. – Execute User Acceptance Testing as needed. – Coordinate system compliance activities, such as system periodic reviews and system access reviews. – Consult with business teams to ensure compliance requirements are built into service contracts and ongoing monitoring of key supplier processes. – Perform software/IT supplier audits and assessments. – Support the investigation and documentation of applicable computer systems quality/data integrity/security incidents/issues as necessary. – Update Policies and Procedures as appropriate. – Support the collection and reporting of quality metrics, specifically computer system compliance metrics and KPIs. – Support various data quality projects associated with both GxP and non-GxP systems. Professional Experience/Qualifications

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5+ years of experience in computer system validation and/or IT Quality Assurance in a Clinical and/or GMP setting. Experience working with Outsourced IT systems, Software as a Service, and Quality Systems development, preferred. – –

Experience conducting internal/external audits and supporting audits and regulatory inspections. – –

Working knowledge of regulations for electronic systems validation and data integrity (e.g., 21CFRPart 11, EU Annex 11, FDA/PICS Data Integrity Guidance). – –

Experience with Sarbanes-Oxley,Data Privacy, Veeva, and Sharepoint is a plus. – –

Must have excellent attention to detail, time management and investigative skills, as well as ability to manage multiple priorities with aggressive timelines. – –

Must have strong written and oral communication skills. – –

Able to influence and work within a team environment. Education

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University degree or higher in life sciences or related fields is required. 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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