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Job #03012

About our client Our client is a rapidly growing biotech company headquartered in Texas 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 Director of Quality Assurance Texas Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee compliance activities for the company’s operations 2) Perform audits of clinical trial master files 3) Conduct internal and external GCP audits 4) Perform quality audits at clinical trial sites including for-cause audits clinical database audit prior to lock clinical study report audit 5) Conduct document audits (protocol, CRFs and IB) 6) Oversee Corrective and Preventative Action (CAPA) System 7) Oversee and manage personnel in overseas offices in India 8) Support validated computerized systems 9) Oversee SOP management, reviewing and approval as well training program 10) Train on audit readiness and behavior 11) Oversee document control Requirements 1) BS in Chemistry, Biology or a related field 2) 10+ years of experience in quality management 3) Minimum 3 years of experience in quality management in the pharmaceutical industry 4) Experience in FDA & EMEA regulatory inspections, auditing 5) In-depth knowledge of cGMP, cGLP and cGCP regulations 6) Ability to manage overseas (India) projects and operations 7) Willingness to travel internationally (up to 30%)