This position will lead NBI’s QA function and will have QA responsibility for all NBI GxP activities from GLP through to GCP. The positions responsibilities include, but are not limited to: develop Quality Systems and maintain NBI operations, both internal and external, in regulatory compliance with appropriate legislation and GxP guidance issued by FDA, EU and ICH; develop and manage budgets; recruit and manage staff; develop and implement appropriate systems for employee GxP training; manage internal and external GxP audits; ensure that NBI adheres to highest industry quality standards; manage a network of external consultants covering all aspects of GxP; develop and conduct of mock inspections ensuring that NBI and the CMOs are inspection-ready; and review and approve clinical supply batch records, clinical packaging and distribution, and product release. In addition, the position will be responsible for the development and implementation of appropriate Quality Systems for a commercial organization, including batch release, complaint handling and recall procedures.
B.S. degree in a life science is required with a minimum of 10 years relevant experience in the pharmaceutical industry is required. Previous supervisory experience is required. Broad pharmaceutical industry experience in Quality Assurance with current US and international knowledge of regulatory compliance requirements across all aspects of GxP. Successful candidate must have expertise in Quality Systems both pre- and post-NDA approval and have current knowledge and expertise in GMPs and GLPs. A working knowledge of GCPs is required. Incumbent must have a commitment to detail and ability to think strategically as well as effectively prioritize when working on multiple projects. Strong leadership skills are required as are exceptional communication skills, creativity and the ability to interact with all levels of NBI management and external CMOs. Minimum of 10% travel is required.