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Job #03255

About our client Our client is a world-leading medical device manufacturer. They focus on providing the finest quality engineered products. With over 2000 products for various surgical procedures they have built up a strong customer base across the US and in 50 countries globally. This is a great opportunity for the right candidate! Position Location Director of Quality Assurance Florida 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) Support validated computerized systems 8) Oversee and manage personnel in overseas offices in India 9) Train on audit readiness and behavior 10) Oversee SOP management, reviewing and approval as well as training program 11) Oversee document control Requirements 1) MS in Chemistry/Biology or a related field 2) 12+ years of experience in quality management 3) Minimum 5 years of experience in quality management in the pharmaceutical industry 4) Experience in FDA & EMEA regulatory inspections and 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 40%)