Manager Quality Assurance & Compliance

    Covance
    Raleigh, NC 27601
    Full-time
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    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.

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    Posting ID: 584170847Posted: 2020-11-03