Manager Quality Assurance & Compliance

Job Overview:

Covance is seeking candidates for Manager Quality Assurance & Compliance. The Manager Quality Assurance & Compliance can be remotely located anywhere within the United States or Canada.

 Manage and support Clinical QA needs of assigned clients and their respective clinical trial programs. Plan, manage and conduct monthly QA to QA meetings with assigned client QA contacts. Develop, manage and maintain Quality Agreements for assigned clients. Provide GCP support and consultation to internal Covance project teams. Attend study team meetings for Clinical QA input as needed. Provide Inspection Readiness support to Covance teams and respective clients. Provide Inspection Management support for Covance and client inspections including overseeing development of inspection responses, QC review of responses, client communications, preparing daily summaries, managing inspection mailbox & tracker, and Inspection follow-up. Support the Client Interactions group for client audits including onsite client audit support when necessary. Participation in Joint Operating Committee meetings. Education/Qualifications:University or College Degree (BA/BS, life science preferred) or equivalent experience. Experience:Must have at least 5 years direct GCP QA experience in a CRO or sponsor quality organization. Must have strong working knowledge and application of GCP, ICH GCP and local regulations. Must have strong interpersonal and communication skills and the ability to effectively work with QA representatives of Covance clients who maybe be of equal or higher level. Must have working knowledge of CAPA and CAPA processes. Must have ability to travel up to 10%. Prior experience in supporting client audits and regulatory inspections.

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