Job: Senior Manager/Associate Director, Small Molecule Quality, TG Therapeutics, Raleigh or Remote, NC
The Senior Manager/Associate Director, Small Molecule Quality, reports directly to Director of Small Molecule Quality. He/she is responsible for supporting GMP activities performed at TGTX and Contract Manufacturing Organizations responsible for the manufacturing, testing and packaging of TGTX products both in clinical development and commercial distribution stages.
The role would manage CMO compliance with cGMP and quality systems, including but not limited to change control, manufacturing deviations, laboratory investigations including OOS results, process, equipment and facilities validation and qualification, analytical method validation and transfer, technology/site transfer, retain sample management, reference standard management and adherence to the Quality Agreement.
• Perform batch record review and batch disposition for GMP intermediates, APIs, drug products including packaging records to support commercial and clinical manufacturing. Review analytical data as needed / applicable.
• Review protocols and reports for stability, validation and other studies, COAs, COC, and other development and GMP documents.
• Work with CMOs to conduct manufacture deviation and laboratory investigations. Review and provide comments, perform risk assessments of impacted product and tracking and approval of CMO deviations and investigations and generation and implementation of associated CAPAs.
• Conduct complaint investigations for both clinical and commercial products. Work with CMOs to adequately address complaints, identify trends, assess product impact and complete complaint investigations within TGTX quality systems.
• Work with CMOs and TGTX partners to evaluate and determine impact to product and regulatory submissions and implement change controls both internally at TGTX and at CMOs.
• Work with internal TGTX CMC, Regulatory and Supply Chain/Logistics to gain agreement on priorities, impact and execution plans to support commercialization of new products and ongoing commercial operations.
• Support person in plant initiatives at CMOs as needed both domestically and internationally.
• Travel approximately 15-20% of time including visits to TGTX offices and CMO manufacturing sites (both domestic and international). Frequency of travel may increase for short durations in order to meet critical business needs.
• 7-15 years’ experience in a GMP Quality Assurance, Quality Control, development or manufacturing environment
• Experience with CMO management is required, i.e. either worked for or with CMOs in a current or previous job
• Broad working knowledge of global regulations (i.e. ICH guidance, FDA/EMA GMP regulations, etc.) for manufacturing, packaging and distribution of API and finished products
• Critical reasoning skills and demonstrated ability to assess impact of planned and unplanned changes on product quality
• Strong organizational skills
• Ability to work in a fast-paced environment, e.g. manage multiple projects to ensure compliance and meet business needs
• Highly effective oral and written communication skills
• Small molecule experience highly preferred