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Compliance and Quality Strategist

3 weeks ago

Bloemfontein, Orange Free State, South Africa IQVIA Full time
About the Role

The Compliance and Quality Lead is a senior member of the Quality and Compliance Team responsible for monitoring and maintaining internal compliance in line with external regulations and requirements, as well as internal policies, to meet quality expectations.

Key Responsibilities:
  • Subject Matter Expertise
    • Be a subject matter expert within the group and provide advice and information to IQVIA staff on quality control processes
  • Quality and Compliance Issue Identification and Resolution
    • Identify quality and compliance issues, provide solutions, and preventative actions
  • Team Leadership and Development
    • Demonstrate commitment to exploring optimal ways of working
    • Set standards for the team
    • Develop, maintain, and train Policies, SOPs, Work Instructions. Liaise promptly with process owners/document authors in case of questions
  • Audit and Compliance Training
    • Smartsolve Quality Management System administrator
    • GCP Training Records management in collaboration with Training manager
  • Collaboration and Communication
    • Primary contact for IQVIA Quality and Compliance Team
    • Coordinating compliance training with the medical director/training manager including Code Clinic agendas, 'HOT TOPICs' and other areas of identified need
  • Leadership and Mentoring
    • Take a leading role in providing training, guidance, and mentoring, including standardised measurements to ensure consistency across teams and best practice is adopted
  • Process Improvement and Change Management
    • Lead role in proposing, developing, evaluating, and implementing process changes and tools and monitoring their adoption and benefits
  • Client Collaboration and Relationship Building
    • Understand external client's compliance needs and ensure internal policies and activities meet this and vice versa; collaborate with AL for onboarding and EBR on compliance aspects
  • Escalation Point and Regulatory Knowledge
    • Act as escalation point for Third Pair of Eyes [TPOE] review
    • Keep abreast of current industry trends, knowledge, developments and advances in area e.g. attending and contributing to regulatory code compliance workstreams

Additional Responsibilities:

  • Manage daily assignments, planning and directing work, and take responsibility for managing workload for assigned projects and tasks, in collaboration with senior staff