Covance Job - 34376420 | CareerArc
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Company: Covance
Location: Raleigh, NC
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

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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