Open Position
Title: Associate Director, Quality Operations – Lab QA
Location: Flexible, US
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
The Associate Director will report to Head, Quality Operations – Lab QA. He/she will provide laboratory QA support for TG’s Biologics commercial and clinical development programs. TG products span early to late-stage clinical development and commercial biologics manufactured by various contract development and manufacturing organizations.
The Quality Operations team consists of Lab QA, Manufacturing QA, and GMP/GDP Compliance functions, and this team is responsible for supporting all Biologics CMC programs in compliance with established TG procedures, cGMP, regulatory submissions, quality agreements, and other applicable guidelines and regulations.
Key Responsibilities
––Vendor management of contract laboratories. Facilitate routine external meetings, coordinate planning and delivery of testing results, lead implementation, and manage issue resolution.
––Review testing execution by CDMOs/CTLs, generate internal COAs, produce batch analysis and stability tables, and respond to emerging trend performance of drug substance and drug product across clinical and commercial CMC programs
––Capture records in Veeva for QMS activity at CDMO/CTLs, such as quality events, deviations, investigations, OOS/OOT, CAPA, Effectiveness checks, etc.
––Collaborate with Analytical Development group as needed, seeking additional technical support for test method implementation, troubleshooting, performance monitoring, and OOS/OOT investigations
––Drive change management in Veeva for implementation and modification of Quality testing related lifecycle documents (i.e. test methods, specifications, stability protocols, and related technical documents)
––Design and lead new initiatives and process improvements to Laboratory QA processes, including business tools, escalation norms, communication pieces
––Author, review, or approve lifecycle documents governing the Laboratory QA function, including SOPs, analytical methods, specifications, stability protocols/reports
––Review analytical method transfer/validation protocols, reports, and implementation plans
––Author and/or review APQRs, CTD sections of regulatory submissions, supplements, variations, and updates (e.g. BLA, IND, MAA, IMPD)
––Ensure critical reagents and reference standards are qualified and adequately supplied for clinical and commercial CMC programs
––Maintain compliant data integrity practices for document originated by CDMO/CTLs
––Participate in supplier qualification audits, due diligence, and/or health authority inspections of CDMO/CTLs
––Support product complaints, stock recovery/product recall, field alert and other quality events and regulatory actions as needed
––Author and/or review content of CDMO/CTL Quality Agreements
––Travel approximately 10-20% of the time (domestic and international). The frequency of travel may increase for a short duration to meet critical business needs.
Professional Experience/Qualifications
––Minimum of 10 years’ experience in GMP Quality Control/Quality Assurance/Quality Systems, Microbiology or Analytical Development in biopharma/pharmaceutical industry
––Experience with data integrity assessments or remediation within an organization or at CMOs / CTOs
––Hands-on experience in providing Analytical, QC or Microbiology support for clinical and commercial manufacturing, tech transfers, product launches and ongoing commercial supplies
––Knowledge and expertise in principles and practices of cGMP for biologic drug substance, drug product and/or aseptic manufacturing experience is a plus
––Experience with CMO / CTO management (e.g. worked with or for CMOs / CTOs)
––Broad working knowledge of global regulations (i.e. ICH guidance, FDA/EMEA GMP regulations, etc.) for manufacturing, testing, packaging and distributing drug substances and drug products
––Direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plus
––Demonstrated ability to broadly assess regulatory compliance audit findings and implement appropriate CAPAs at CMOs / CTOs
––Experience with assessing validation requirements for laboratory, facilities and equipment
––Excellent oral and written communication skills for effectively interfacing with internal and external organizations
––The ability to manage multiple priorities with aggressive timelines and changing priorities
––Ability to troubleshoot, identify root causes and systematically resolve problems
––Ability to strategize (i.e. see ‘big picture’) and provide attention-to-detail when needed
Education
––Bachelor’s Degree in a scientific discipline is required; advanced degree is a plus
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.