Manager Quality Assurance & Compliance

Company: Covance
Location: Durham
Posted on: November 20, 2020

Job Description:

Job Description 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. * 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. #LI-REMOTE

Keywords: Covance, Durham , Manager Quality Assurance & Compliance, Other , Durham, North Carolina