Quality Assurance Manager

at  Liverpool School of Tropical Medicine

Liverpool L3, England, United Kingdom -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate21 Nov, 2024GBP 44263 Annual23 Aug, 2024N/AChildren,Clinical Trials,Higher Education,ItNoNo
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Description:

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.
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As QA manager, you will be responsible for ensuring that all aspects of the work conducted by the respective units adheres to regulatory requirements, industry standards, and LSTM policies. You will play a critical role in maintaining the integrity, reliability, and quality of our clinical trial operations.
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Additional responsibilities will include implementing and maintaining the Quality Management Systems (QMS), including but not limited to quality assurance processes, staff training, risk management and monitoring.
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PLEASE REFER TO THE JOB DESCRIPTION FOR FULL DETAILS ON ROLE RESPONSIBILITIES

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QUALIFICATIONS AND SKILLS REQUIRED:

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  • Educated to Degree Level or equivalent.\r
  • Evidence of professional CPD.\r
  • Quality Assurance qualification or equivalent relevant experience.\r
  • Experience and knowledge of working within clinical trial legislative frameworks, including Clinical Trials involving Investigational Medicinal Products (CTIMPs).\r
  • Experience of working in a Higher Education environment.\r
  • Experience of a risk-based approach to management and conduct of clinical trial activities.\r
  • Application Process: To apply for the position please follow the apply link and upload your CV and covering letter.\r

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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.
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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.
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Responsibilities:

YOUR RESPONSIBILITIES WILL INCLUDE:

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  • 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.\r
  • Providing leadership and guidance on quality assurance, overseeing day-to-day operations and fostering a culture of quality and compliance within the units.\r
  • Supporting the Trial Teams to ensure the safe conduct of all clinical trials though leadership of highly effective pharmacovigilance reporting and oversight systems.\r
  • 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.\r
  • Supporting the clinical trial manager to craft and deliver clinical research projects, against agreed project achievements and quality standards.\r
  • 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.\r

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REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Software Testing, Clinical Pharmacy

Graduate

Proficient

1

Liverpool L3, United Kingdom