Covance

  • Mgr Quality Assurance

    Job Location(s) CN-Shanghai | CN-Beijing | CN-Guangzhou
    Job Number
    2018-20970
    Job Category
    Quality Assurance
    Position Type
    Full-Time
  • Job Overview

    Summary of Responsibilities:

    • 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 as appropriate to the QA relationship with the client.
    • Develop, manage and maintain Quality Agreements for assigned clients.
    • Provide QA support to TAs as assigned, working across a variety of studies within the TA, including discussion of quality matters and provision of required metrics.
    • Provide GCP support and consultation to internal Covance project teams.
    • Attend study team meetings for Clinical QA input as designated.
    • 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.
    • Assist with Inspection follow-up, including review of inspection report responses and lessons learned activities.
    • Support the Client Interactions group for client audits including onsite client audit support when necessary.
    • Assist with review of responses to client audit findings.
    • Participation in other client meetings as required (such as bid defenses, QA face to face meetings, Joint Operating Committee meetings).
    • Provide local regulatory agency expertise as required based upon knowledge and experience.

     

    Education/Qualifications

    • University or College Degree (BA/BS, life science preferred) or equivalent experience;

     

    Experience

    • Must have at least 3 - 5 years direct GCP QA experience in a CRO or sponsor quality organization;
    • Must have strong working knowledge and application of GCP, ICH GCP, regional 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 20%;
    • Prior experience in supporting client audits and regulatory inspections.

     

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