Executive Director

Executive Director About the Company Innovative biopharmaceutical company specializing in therapies for hematologic disorders IndustryPharmaceuticals TypePrivately Held Founded2015 Employees51-200 Categories PharmaceuticalsBiotechnologyHealth CareAcademic ResearchGenomicsClinical CareManufacturingMedicineChemical Products About the Role The Company is seeking an Executive Director of GMP Quality Assurance for Small Molecules to play a pivotal role in the quality strategy and deliverables for its expanding portfolio. The successful candidate will be responsible for ensuring phase-appropriate cGMP manufacture, testing, and supply, and will represent the Quality function on various internal and external teams. This includes overseeing compliance at external vendors, establishing quality agreements, and leading all quality-related activities from IND to commercialization. The role demands a leader with a proven track record in building a quality culture, leading quality assurance operations, and a deep understanding of US and ex-US regulations for small molecule products. Applicants must have a BA/BS degree, with an advanced degree being a plus, and over 15 years of GMP quality operations experience, or a combination of advanced degrees and experience. The ideal candidate will have a strong background in CMC, development programs, and quality management, and be adept at making science-driven, risk-based decisions. The role requires a leader who can foster a positive workplace culture, ensure accountability, and be committed to continuous improvement. The Executive Director will also be expected to travel 20-30% of the time and must be prepared to take on any other business needs as identified by their manager. Hiring Manager TitleSenior Vice President of Quality Travel Percent30% Functions CEO/PresidentNon-Profit ManagementOperationsGeneral ManagementStrategy

Created: 2025-02-13