Open Position
Title: Manager/Senior Manager, Quality Operations
Location: Flexible, US, working remotely with periodic visits to company headquarters located in Morrisville, NC for meetings and collaborations with other teams.
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 Manager/Senior Manager of Quality Operations will report to the Associate Director, Quality Operations. They will be part of the Quality Operations team that provides quality oversight for TG Therapeutic’s (TG’s) biologics commercial and clinical development 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.
Key Responsibilities
– Oversee CMO to ensure products manufactured are produced in accordance with regulatory requirements, product registrations, and quality agreements
– Perform batch record reviews and lot dispositions per established procedures
– 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 clinical and 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
– 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
– Travel approximately 10% of time (domestic and international), including visits to CMOs and TG’s offices in NC, NJ, and NY; 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.
––Thorough knowledge of GMP regulations; direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plus; direct interaction with qualified person (QP) is a plus
––Experience supporting clinical phase through 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.