Quality Manager - QA Compliance - GCP

Responsibilities:

  • To provide support and participate in internal and external, and other regulatory agency inspections (FDA, EMA, etc)
  • Take part in the GCP, GCLP and GLP Compliance Programmes
  • To lead and manage the CAPAs, Deviations, Audits and Vendor Quality Management Programs
  • To lead, Develop and manage the Compliance staff and provide coaching and mentoring on Quality Management Systems
  • To participate in internal and external audits, and support vendor quality management activities
  • To conduct compliance risk assessments, trend analysis and provide recommendations for compliant business activities
  • To supply feedback to the HCQA/DOQ and other senior management on any trends and serious quality issues or non-compliances that are detected by CQA staff whilst carrying out duties for GCP, GCLP, GCLP and GVP activities
  • To liaise with auditors to ensure that the CAPAs resulting from audits associated with the assigned programmes and studies are allocated a CQA CAPA owner and closed out appropriately and in a timely manner
  • To author, reviews and/or authorise Standard Operating Procedures (SOPs)
  • Member of the Quality Leadership Team.

 

Experience:

  • A Batchelor’s degree or equivalent in scientific discipline
  • Extensive experience in clinical/pre-clinical research in a healthcare company, with demonstrated knowledge and experience of auditing/inspection techniques, including study specific, vendors, internal process/system, pharmacovigilance activities, regulatory submissions, and documentation audits, as well as experience of related quality assurance principles applicable to clinical trials
  • Demonstrates a “can do” approach
  • Excellent attention to detail and the ability to identify the root cause of problems
  • Competency in use of electronic systems for management and tracking of audits, audit reports and CAPAs
  • Previous people leadership experience preferred
  • Previous experience working with FDA (CBER) and participating in regulatory agency inspections

 

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