Quality Assurance Manager

at  Liverpool School of Tropical Medicine

QUALIFICATIONS AND SKILLS REQUIRED:

• Educated to Degree Level or equivalent.
• Evidence of professional CPD.
• Quality Assurance qualification or equivalent relevant experience.
• Experience and knowledge of working within clinical trial legislative frameworks, including Clinical Trials involving Investigational Medicinal Products (CTIMPs).
• Experience of working in a Higher Education environment.
• Experience of a risk-based approach to management and conduct of clinical trial activities.
• Application Process:
  Due to the volume of applications, we receive, we may close our vacancies early. It is therefore advisable to apply as early as possible if you would like to be considered for a role.
  Please note that the successful candidate will be required to undergo an enhanced DBS and/or other international criminal record check prior to appointment and at regular points during employment. The outcome must be satisfactory to LSTM, as the duties of this post will involve direct and/or indirect contact with vulnerable adults and/or children.

YOUR RESPONSIBILITIES WILL INCLUDE:

• Management of Quality Management System (QMS), ensuring alignment with relevant regulatory guidelines including ICH-GCP, country specific regulations, Human Tissue Act and Data Protection Regulation.
• Providing leadership and guidance on quality assurance, overseeing day-to-day operations and fostering a culture of quality and compliance within the units.
• Supporting the Trial Teams to ensure the safe conduct of all clinical trials though leadership of highly effective pharmacovigilance reporting and oversight systems.
• Leading the quality function in assisting researchers in planning new clinical research studies and trials to ensure that all aspects of the regulations have been considered; provide advice on development of protocol and associated documents.
• Supporting the clinical trial manager to craft and deliver clinical research projects, against agreed project achievements and quality standards.
• Coordinating the design and delivery of training necessary to ensure high standards and regulatory compliance across all staff groups working on the clinical research portfolio. This includes leading development of specific training according to demand.