Karyopharm Therapeutics is a clinical-stage pharmaceutical company, based in Newton, MA, USA, focused on the discovery, development and commercialization of novel, first-in-class agents targeting nuclear transport for the treatment of cancer and other major diseases. Karyopharm is the industry leader in oral Selective Inhibitor of Nuclear Export (SINE) technology, developed to address a central mechanism of oncogenesis via the inhibition of exportins specifically XPO1. Selinexor, Karyopharm’s lead candidate, has been administered to patients with hematologic malignancies or solid tumors in clinical trials worldwide. Karyopharm is currently preparing for its first potential U.S. commercial launch in 2019.
The Associate Director of Quality Assurance will: Provide strategic and operational leadership for the quality oversight of both drug substance and drug product manufacturing, packaging, labeling and distribution. Support Quality Management Systems within GMP operations to ensure phase appropriate quality systems are used throughout the lifecycle of the products. Manage activities and projects to meet company objectives through manufacturing and product development, including review, approval and QA oversight of all aspects of: clinical and commercial manufacturing at CDMOs, packaging and labeling, warehousing and the global distribution of clinical and commercial API and Drug Product. Responsible for ensuring all company, regional, and global standards and regulations are met, and that the department is developed and maintained to a standard that ensures the quality of products and materials produced by our contracted partners. Responsible for implementation and sustainment of commercial quality systems.