Quality Assurance Manager

6 days ago


Liverpool, Liverpool, United Kingdom Lifelancer Full time
Job Description

Job Title: Quality Assurance Manager

Job Summary:

We are seeking a highly skilled Quality Assurance Manager to join our team at Lifelancer. As a Quality Assurance Manager, you will play a critical role in ensuring that all aspects of our clinical trial operations adhere to regulatory requirements, industry standards, and company policies.

Key Responsibilities:

  • Quality Management System (QMS) Management: Ensure alignment with relevant regulatory guidelines, including ICH GCP, country-specific regulations, Human Tissue Act, and Data Protection Regulation.
  • Leadership and Guidance: Provide leadership and guidance on quality assurance, overseeing day-to-day operations, and fostering a culture of quality and compliance within the units.
  • Pharmacovigilance Reporting and Oversight: Support the Trial Teams to ensure the safe conduct of all clinical trials through leadership of highly effective pharmacovigilance reporting and oversight systems.
  • Quality Function Leadership: Lead 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.
  • Clinical Trial Project Management: Support the clinical trial manager to craft and deliver clinical research projects against agreed project achievements and quality standards.
  • Training and Development: Coordinate the design and delivery of training necessary to ensure high standards and regulatory compliance across all staff groups working on the clinical research portfolio.

Qualifications and Skills:

  • Educational Background: Educated to Degree Level or equivalent.
  • Professional Development: Evidence of professional CPD.
  • Quality Assurance Qualification: Quality Assurance qualification or equivalent relevant experience.
  • Clinical Trial Experience: Experience and knowledge of working within clinical trial legislative frameworks, including Clinical Trials involving Investigational Medicinal Products (CTIMPs).
  • Higher Education Experience: Experience of working in a Higher Education environment.
  • Risk-Based Approach: Experience of a risk-based approach to management and conduct of clinical trial activities.


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