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Job #02493

About our client Our client is a rapidly growing biotech company headquartered in Maryland that is focused on the development and commercialization of various therapeutics for disorders of the nervous system. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Manager/Director of Quality Assurance Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee compliance activities for company’s operations 2) Conduct internal Good Clinical Practice audits 3) Perform audits of clinical trial master files 4) Conduct audits of Medical Organization GCP Contract Vendors 5) Perform quality audits at clinical trial sites, including for-cause audits clinical database audit prior to lock clinical study report audit 6) Conduct document audits (protocol, CRFs and IB) 7) Oversee Corrective and Preventative Action (CAPA) System 8) Support validated computerized systems 9) Oversee SOP management, review and approval and training program 10) Train on audit readiness and behavior 11) Oversee document control Requirements 1) BS in Chemistry, Biology or a related field, with 10 years of experience in quality management 2) 5+ years of experience in quality management in the pharmaceutical industry 3) Experience in FDA & EMEA regulatory inspections, auditing 4) Extensive knowledge of cGMP, cGLP and cGCP regulations