Director of Quality

SL7 1AA, Marlow
Competitive Salary
02 Sep 2019
02 Oct 2019
Full Time
Contract Type
Experience Level

Compliance and Quality team, you will be responsible for the following activities:

  • Lead the regulated quality approach across OPEN VIE and other regulated practice areas
  • Enhance current systems and implement required changes to working practices to ensure 
    QMS processes are part of organisational DNA
  • Ensure the control, coordination, planning and continuous improvement of systems and processes to ensure projects follow required Good Clinical Practice (GCP) and QMS rigour
  • Develop and maintain the appropriate Quality Plan and Manual
  • Maintain and manage required Standard Operating Procedures (SOPs)
  • Support the Information Security Officer (ISO) for the organisation in quality best practices and approaches including the systems development lifecycle (SDLC)
  • Monitor and support the quality processes of individual practices that work to accredited standards (e.g. ISO compliance)
  • Maintain existing accreditations as well as lead extension of new accreditations if appropriate
  • Centrally sponsor and lead QMS and input into strategy development
  • Be responsible for leading and/or supporting the external and internal auditing activities and plans (limited travel)
  • Work collaboratively with colleagues to achieve results
  • Support the healthcare data collection teams in reviewing study methodologies

What you will bring:

  • Minimum of 10 years’ relevant experience of working in a senior quality role in healthcare research, Pharma, agency or a clinical research organisation
  • Experience of setting up and running QMS in the Pharma environment
  • Graduate or relevant healthcare qualification
  • Strong leadership skills and experience of creating change
  • Excellent communication and relationship building skills (verbal and written)
  • A flexible attitude, self-motivated and an ability to work independently
  • Persuasive, positive and assertive attributes
  • Systematic, logical, thorough and precise thinking and execution
  • Sound IT skills - knowledge of Word, Excel and PowerPoint as well as QMS