Director of Quality

Location
SL7 1AA, Marlow
Salary
Competitive Salary
Posted
03 Sep 2019
Closes
03 Oct 2019
Ref
JM15DQ
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive

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