Open Position
Title: Senior Manager, Research & Development (R&D) Quality
Location: Remote, USA (travel to the TG headquarters in Morrisville, NC on occasion as required.)
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 U.S. Food and Drug Administration (FDA) approval 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, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit www.tgtherapeutics.com.
Role
The Senior Manager of R&D Quality is responsible for contributing to the development and maintenance of a quality culture at TG and supporting GxP Quality Assurance (QA) activities across the R&D Quality department, including but not limited to preclinical and clinical studies (Phase 1-4) for Briumvi life cycle and TG’s clinical pipeline to develop novel therapies for various autoimmune diseases. He/she is responsible for organizing, managing, and executing R&D Quality processes and related project management activities. This position reports to the Director of R&D Quality.
Key Responsibilities
––Support corporate quality and compliance of R&D activities and outcomes per applicable regulations, standards, and guidelines.
––Proactively identify, document, and escalate quality/compliance issues and discrepancies; propose solutions for resolution.
––Maintain processes for tracking and monitoring execution of R&D Quality activities; assist in the reporting and evaluation of GCP quality metrics and identification of trends.
––Support investigations into significant quality issues, facilitate identification of root causes, and assist in developing appropriate corrective and preventive actions (CAPAs) and effectiveness checks (as applicable); oversee the management of deviations and CAPAs through completion.
––Contribute to the development, implementation, and maintenance and QA approval of applicable GxP-controlled documents (e.g., SOPs, Policies, Forms, Work Instructions, etc.).
––Support QA oversight of R&D suppliers/vendors, including quality issues and annual reviews.
––Facilitate R&D Quality-led meetings, including preparing meeting agendas, drafting meeting minutes, documenting action items, and tracking follow-up.
––Participate in and support audits and inspections and inspection readiness activities as needed.
––Actively engage in continuous improvement initiatives of TG processes and systems.
––Identify, participate in, and/or mitigate GCP activities and process improvement initiates as requested by management.
––Perform other related duties as assigned.
Travel 10-15% to TG’s offices to attend meetings, etc., as required.
Professional Experience/Qualifications
––Minimum of 5+ years working experience in a GxP regulated setting in the biopharma/pharmaceutical industry; GCP QA or clinical operations experience is required.
––Solid understanding of GxP, FDA, ICH GCP and applicable global regulations and guidance for clinical development.
––Demonstrate accountability and ability to deliver expected results according to agreed-upon scope and timelines.
––Excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines.
––Ability to effectively interact with different functional groups at varying levels of management and internal stakeholders within the company.
––Strong written and oral communication skills.
––Experience with SharePoint, Veeva, and other quality systems preferred.
Experience working in a small biotech setting preferred.
Education
––Bachelor’s degree in life sciences or related field or a combination of relevant education and applicable job experience 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.