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Director Clinical QA

3 months ago

Leeds, United Kingdom Pharmiweb Full time

Job Title: Head of/ Director Quality Assurance (GCP)

Location: Central London (Hybrid)

Type: Full-time, Permanent

 

A renowned organisation specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors seeks a dedicated Head of/ Director Quality Assurance. Embracing a culture of excellence and innovation, we are committed to advancing medical research and contributing to the development of transformative therapies.

 

Responsibilities:

  • Oversee quality assurance initiatives throughout the organisation, fostering a culture of continuous improvement to ensure compliance with ICH-GCP Guidelines and other regulatory standards.
  • Identify and communicate observations or deviations encountered in day-to-day operations, actively participating in their resolution to maintain quality standards.
  • Track, assess, and approve Non-Conformances (NCs)/Incident Reports (IRs) through the electronic Quality Management System (eQMS), driving continual quality enhancement.
  • Review and approve Quality Documents to ensure adherence to ICH-GCP standards and process improvements, leveraging the eQMS.
  • Prepare for and host external Sponsor audits or Inspections, facilitating timely provision of documentation and addressing findings through CAPAs tracked in the eQMS.
  • Conduct QA risk assessments for studies, systems, and vendors to develop audit schedules, coordinating and performing audits as Lead Auditor, and managing timely distribution of audit reports and closure of Corrective and Preventive Actions (CAPAs).
  • Prepare and deliver presentations at Quality Council and Executive Board meetings, ensuring effective communication of QA matters.
  • Review Computer System Validation (CSV) documents and act as QA approver when necessary.
  • Organise and manage the QA mailbox for timely responses and maintain the QA shared area for streamlined access to resources.
  • Conduct QA training for staff, promoting a culture of high-quality standards throughout the organization.
  • Supervise and train other QA personnel, effectively managing workload distribution and monitoring task completion.

 

Qualifications and Experience:

  • Proficient knowledge of Quality Assurance principles within the Pharmaceutical Industry.
  • Strong understanding of Quality Management Systems in the pharmaceutical sector.
  • Thorough familiarity with ICH-GCP and GMP guidelines.
  • Experience in hosting Sponsor audits and/or Regulatory inspections.
  • Demonstrated ability to organize and conduct internal and/or vendor audits.