TG Therapeutics, Inc.
Manager/Sr. Manager, Computer Systems Compliance
TG Therapeutics, Inc., Trenton, New Jersey, United States,
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Open Position
Title: Manager/Senior Manager, Computer Systems ComplianceLocation: 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. 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). 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. Responsibilities include: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
5+ years of experience in computer system validation and/or IT Quality Assurance in a Clinical and/or GMP setting.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
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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Open Position
Title: Manager/Senior Manager, Computer Systems ComplianceLocation: 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. 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). 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. Responsibilities include: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
5+ years of experience in computer system validation and/or IT Quality Assurance in a Clinical and/or GMP setting.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
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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