Manager, Quality Assurance
Covance
Warsaw, Poland
1 d. temu

Job Overview :

The Manager, Quality Assurance can work home or office based anywhere within the EMEA region.

  • 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 :

    Minimum Requirements

  • University or College Degree (BA / BS, life science preferred) or equivalent experience;
  • Must have a wealth of 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 20%;
  • Prior experience in supporting client audits and regulatory inspections.
  • Experience :

  • University or College Degree (BA / BS, life science preferred) or equivalent experience;
  • Must have a wealth of 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.
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