The primary responsibility of this position is the management and continuous improvement of the GCP Quality System, leading and management of GCP audits to assure that all aspects of clinical trials conducted have been executed in compliance with applicable FDA, ICH GCP Guidelines and other government and/or country specific regulations. Primary duties include but are not limited to liaises with colleagues at parent company in France, various internal departments and external groups including Contract Research Organizations (CROs), investigator sites ensuring a high level of quality and consistency across the programs and studies, development of the master audit plan as a means to ensure compliance with appropriate policies and procedures and contributions to due diligence activities as appropriate. This position will serve in an advisory/consultative role in compliance related manners, assist clinical program teams in implementing corrective and preventive actions and enable program teams to be inspection ready and support a culture of sustainable compliance. Under the direction of the Head of Quality Assurance, this position is responsible for providing strategic direction and compliance oversight to the clinical programs being managed by the LFB-USA Clinical Development organization.
Bachelor’s degree in a life science required; Master’s Degree in management or scientific discipline preferred. At least 10 years of pharmaceutical/biotechnology experience. Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance and GCP auditing.