Covance Mgr Quality Assurance in Taiwan

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.

Job Number 2018-20970

Job Category Quality Assurance

Position Type Full-Time

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