Open Position
Title: Manager/Senior Manager – Quality Operations (Commercial Manufacturing)
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 Manager/Senior Manager of Quality Operations will report to the Director, Quality Operations. They will be part of the Quality Operations team that provides quality oversight for TG Therapeutic’s (TG’s) biologics commercial programs. TG is a virtual company with no in-house manufacturing facilities. TG’s biologics products are manufactured, tested, and packaged by various global Contract Manufacturing Organizations (CMOs). As such, the location of the role is flexible. Some schedule flexibility will be required for the role, with oversight of vendors in various time zones. Some off-hours meetings and work will be required.
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
––Ensure CMO compliance with applicable cGMP regulations, batch records, product registrations, quality agreements and data integrity standards
––Support QA batch record reviews and lot dispositions of commercial drug substance and drug product per established procedures for internal and TG’s business partner use
––Lead quality aspects and provide support to TG’s business partners on QA-related investigations, change controls, lot dispositions, and regulatory requests
––Lead quality aspects and provide support to CMOs in QA-related investigations, change controls, documentation and regulatory requests.
––Conduct and review product and/or lot-related deviations, complaints, CAPAs, change controls and annual product quality reviews (APQRs).
––Review and approve controlled documents, including commercial manufacturing and packaging master batch records, protocols and final reports
––Work with TG Quality Systems and CMC team to ensure quality and technical documentation is delivered to the internal archiving system
––Provide guidance, advice, and support for GMP quality and compliance matters.
––Represent Quality as Person-In-Plant at CMO’s as necessary to support production operations.
––Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained. Contribute to development and improvement of TG Quality System as relevant, such as creation and updating of SOPs
––Participate in developing, reporting, reviewing, and trending of GMP-related Quality Metrics such as Key Performance Indicators (KPIs) in support of the QMS.
––Travel approximately 10% of time (domestic and international), including visits to CMOs and TG’s offices in NC; the frequency of travel may increase for a short duration in order to meet critical business needs.
Professional Experience/Qualifications
––Minimum of 5 years’ experience in GMP Quality or Manufacturing in biopharma/biologics/ pharmaceutical industry; experience in biologics is required.
––Experience working directly with contract manufacturing organizations (CMOs) is required
––Experience in sterile drug product manufacturing is preferred
––Thorough knowledge of cGMP regulations; direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections and qualified persons (QPs) is preferred
––Experience supporting commercial and lifecycle management,
––Experience in oversight of contract manufacturing,
––Proficiency in electronic QMS Software such as Veeva, Trackwise, etc.
––Excellent attention to detail, organizational and time management skills,
––Must have strong written and oral communication skills
Education
––University degree in life sciences or related fields; Post-Graduate work
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.