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Job #02223

About our client Our client is a privately-held, technology-based clinical trials organization that provides key drug development services to pharmaceutical and biotechnology companies involved in the development of new therapeutic drugs and medical devices. The company offers a wide range of services, including project development, project management, study execution at its dedicated site, electronic data capture and management for multicenter trials, and electronic subject recruitment for multicenter trials. Position Location Director/Manager of Quality New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Maintain written Standard Operating Procedures (SOPs) 2) Perform internal audits 3) Provide risk assessment advice to staff 4) Lead GCP compliance improvement initiative 5) Provide training and consultation to departmental personnel 6) Host regulatory authority inspections Requirements 1) Bachelor’s or masters degree in Life Sciences 2) Minimum 3 years' hands-on experience in an Audit/Compliance Department of a CRO, pharmaceutical, or biotech firm 3) In-depth knowledge of Good Clinical Practice (GCP) 4) Excellent written and verbal communication skills