The Senior Quality Aduitor/Manager of GCP Quality. The position will be responsible to assess compliance with , ICH and US FDA regulations and guidelines, and clinical study protocols. Responsibilities include performing audits; internal systems, and of clinical trial sites.This role participates in the development, implementation and maintenance of the corporate GCP Quality Management System and training program. This is a cross-functional position that works in other departments, particularly Clinical Operations, in a collaborative nature as a QA on regulatory topics and interpretations. Strong communication skills , the ability to build internal and external relationships including interactions with clinical investigators and their staff concerning GCP matters, contract research organizations, and clinical laboratories.
Essential Duties And Responsibilities
Karyopharm Therapeutics is a global commercial-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.
Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.