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Job #02600

About our client Our client is a reputable, mid-size CRO that is experiencing unprecedented growth. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Director of Quality Assurance Texas Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee all tasks related to the development, maintenance, management and audit of quality assurance program of ICH-GCP, EU CT Directive and FDA compliant quality 2) Develop and enhance worldwide clinical quality assurance policies 3) Update senior management on the level of compliance with periodic reports, which include recommendations for improvements and training 4) Provide GCP/QA consultation for all company staff 5) Function as contact person for sponsor audits before, during and after their visits 6) Coordinate all aspects of site audits at the sponsor’s request 7) Carry out periodic quality control inspections of all company offices, associated companies and sub-contractor companies 8) Develop and implement audit work plans 9) Keep up-to-date with relevant regulatory guidelines and provide internal training on them 10) Promote quality standards and awareness for all company staff 11) Write regular articles on Quality issues for industry publications 12) Provide global trending/metrics for Quality Assurance 13) Supervise the drafting, reviewing and tracking of SOPs 14) Arrange and participate in all internal training courses on ICH GCP and company SOPs 15) Undertake GLP and GMP inspections as required Requirements 1) Bachelor's degree in a scientific discipline/Master’s preferred 2) 7+ years of clinical quality (GCP) experience 3) 5+ years of experience in personnel management (team of at least 10) 4) 10+ years of clinical experience in the CRO or pharmaceutical/biotech industry 5) Proven track record in both personnel and departmental budget management 6) Expert knowledge of clinical quality assurance, compliance with ICH GCP, SOPs, national/local guidelines and the EU Directive (2004) 7) In-depth knowledge and understanding of FDA regulations and GCPs 8) Excellent communication skills