Quality Assurance Manager

at  Liverpool School of Tropical Medicine

An exciting opportunity has arisen to join our Clinical Sciences team as a Quality Assurance (QA) Manager. The role will be based across our Global Health Trial Unit and Health Clinical Facility, assuming leadership over clinical trial QA operations.
As the Quality Assurance (QA) Manager, you will take on a senior leadership role overseeing and driving the QA operations across the Global Health Trials Unit (GHTU) and Human Challenge Facility (HCF). In this pivotal role, you will develop and shape the QA framework, ensuring alignment with regulatory requirements, industry standards, and LSTM policies while contributing to long-term strategic goals to foster research integrity, reliability, and quality in clinical trial operations.
Your responsibilities will extend to high-level strategic planning and the implementation and continuous improvement of a comprehensive Quality Management System (QMS). This includes leading quality assurance processes, team development, risk management, and quality monitoring to enhance operational efficiency and meet expanding trial demands

QUALIFICATIONS AND SKILLS REQUIRED:

• Educated to Degree Level or equivalent (Masters degree in a relevant field highly desirable)
• Certified Quality Assurance Professional, ideally at an advanced level, or equivalent extensive experience
• Advanced knowledge of clinical trial legislative frameworks
• Significant experience in high-stakes clinical research environments, ideally in global health settings including, early phase and CTIMPs
• Experience of working in a Higher Education environment
• Experienced in a risk-based approach to managing and conducting clinical trial activities.
• Skilled in managing and supporting teams and liaising with a wide variety of stakeholders at all levels.
• Proficient in planning, conducting, reporting, and following up on internal audits, as well as performing root cause analysis and developing remedial action plans.
• Experienced in developing Standard Operating Procedures (SOPs) in compliance with clinical trials regulations, delivering training to multidisciplinary audiences, and adept in advanced quality management software.
  Application Process: To apply for the position please follow the apply link and upload your CV and covering letter
  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:

• Leading the development, implementing, and continuously improving the Quality Management System (QMS) for GHTU and HCF, ensuring alignment with regulatory requirements, fostering a compliance culture, enhancing processes, and driving strategic QA initiatives in collaboration with senior leadership.
• Directing and managing a pharmacovigilance system to ensure clinical trial safety and compliance with evolving standards and SAE reporting requirements.
• Leading quality planning for new clinical trials, implementing risk-based monitoring for high-risk studies, and delivering training to foster a proactive compliance culture.
• Mentoring clinical trial managers, providing expert QC reviews and guidance on regulatory submissions and protocol development, while leading the creation of advanced monitoring and project tracking frameworks to ensure high standards in project delivery.
• Designing and implementing a comprehensive training program to elevate regulatory standards, developing tools for Good Clinical Practice sharing, and representing GHTU and HCF at national and international forums to showcase expertise and foster knowledge exchange.
• Providing line management to support staff development and succession planning, championing equality and inclusivity in QA practices, and ensuring accountability to safeguard vulnerable individuals.