Open Position
Title: Director, R&D Quality
Location: This is a hybrid position, i.e. working remotely with periodic visits to TG’s NC office (Morrisville, NC) for meetings and collaborations with other teams. While an ideal candidate lives within a commuting distance to TG’s NC office, all other strong candidates will also be considered based on his/her overall qualifications.
If you are interested in the below position, please send your resume to [email protected] 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 Director of R&D Quality is responsible for leading the independent QA oversight of internal and external Good Clinical Practices (GCP) and assuring compliance of projects with applicable worldwide regulations and guidelines (e.g. FDA, EMA, ICH, national regulators). This position reports to the SVP, Quality. Travel to TG Offices, or Clinical Sites/CRO will be required approximately 10-15% of the time.
Key Responsibilities
– In partnership with internal Clinical Operations, Clinical Development, Drug Safety, and Pharmacovigilance, Regulatory Affairs, etc., develop mid to long term Quality plans for oversight of internal and external clinical activities;
– Lead a small internal R&D Quality team;
– Lead GCP inspection readiness activities;
– Facilitate risk and gap analyses of existing systems and processes; and propose improvements;
– Act as a strong technical resource to resolve GCP issues based on knowledge of regulations, guidelines, and relevant SOPs;
– Proactively identify quality issues/discrepancies, communicate, and effectively resolve issues in collaboration with internal and external partners;
– Contribute to TG GxP Quality organization by undertaking a variety of roles and assignments to further develop internal processes and personnel;
– Lead, and revise as needed, an effective GCP training program;
– Ensure compliance of clinical development with all applicable regulations and standards;
– Support preparations for and execution of regulatory inspections of TG and its CROs, other GCP/GCLP vendors, clinical sites as necessary;
– Actively engage in activities to influence and meet changing needs of the regulatory environment through QA and other appropriate venues.
Professional Experience/Qualifications
––10+ years of direct experience in GCP Activities, Quality Systems and oversight of drug development lifecycle, clinical/non-clinical research, clinical study monitoring, or pharmacovigilance;
––A minimum of 7 years of previous clinical QA experience;
––Expertise in GCP regulations and guidance of Health Agencies and ICH guidelines;
––Demonstrated leadership skills in mentoring and developing staff, including direct reports;
––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 without authority; experienced team builder;
––Relevant GLP experience is strongly preferred.
Education
––University degree in life sciences or related fields is required;
––Post-graduate work is preferred.
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.