Open Position
Title: Associate Director, Quality Program Manager
Location: Remote but preferably within commuting distance to TG headquarters (Morrisville, NC)
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 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
This role reports directly to SVP, Head of Quality and provides support across the entire GxP Quality function. He/she is responsible for organizing, managing, and executing annual quality project plans, including but not limited to ensuring TG’s overall readiness for and execution of regulatory inspections and external audits.
The successful candidate will have project or program management experience in the biopharma, pharmaceutical, or medical device industry, relevant experience in audit and inspection preparation and management, working knowledge of global GxP standards, and the ability to work effectively with internal cross-functional teams, external partners, and auditors.
Key Responsibilities
––Establish and maintain processes for tracking and monitoring execution of the annual goals and objectives for the Quality organization and various quality teams, and other significant quality-owned or led projects;
––Demonstrate accountability and urgency to define, drive execution, and deliver expected results according to agreed-upon quality project scope and timeline;
––Develop and maintain annual quality calendar, including but not limited to annual management reviews, semi-annual quality councils, quarterly audit reviews, quarterly reviews of critical supplier scorecards;
––Facilitate weekly Quality Leadership Team meetings, including preparing meeting agenda, meeting minutes, action items, and follow-ups;
––Assist Head of Quality to prepare, update and review annual quality budget and quarterly forecasts;
––Create coordinated project/program timelines and verify completion of project deliverables and milestones;
––Identify and mitigate project risks with timely communication to management and relevant stakeholders;
––Work closely with other program managers and functional project managers within the company to ensure alignment between quality and operations teams;
––Travel approximately 10% to TG’s offices to attend meetings as required;
––All other duties as assigned.
Translate complex information from subject-matter experts into lean and clear text; able to draft documents from templates, drafts and synopses
Professional Experience/Qualifications
––Minimum of 7 years’ working experience in a GxP regulated setting in the biopharma/pharmaceutical/medical device industry;
––Minimum of 3 years’ experience in project/program management practices, in the biopharma/pharmaceutical/medical device industry;
––Experience in GxP audits and regulatory inspection preparation or management;
––Working knowledge of global GxP regulations and quality systems;
––Experience with drug development or commercialization projects is desired;
––Experience with working in a small biotech setting is desired;
––Experience with project management, team collaboration, and productivity tools such as Microsoft Project, SharePoint is desired;
––Experience with quality and performance metrics, project management dashboard, etc. is desired;
––Ability to drive participation and accountability without line management authority;
––Ability to support multiple activities and internal resources while maintaining a focus on quality and compliance;
––Ability to produce and present clear, concise, and professionally written communications and presentations;
––Sound technical aptitude and ability to see the big picture.
Education
––University degree 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.