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Quality Assurance Manager

2 months ago

Liverpool, Liverpool, United Kingdom Lifelancer Full time
About the Role

We are seeking a highly experienced Quality Assurance Manager to join our team at Lifelancer. As a Quality Assurance Manager, you will play a critical role in ensuring the integrity, reliability, and quality of our clinical trial operations.

Key Responsibilities
  • Quality Management System (QMS) Leadership: Develop and implement a robust QMS that aligns with relevant regulatory guidelines, including ICH-GCP, country-specific regulations, Human Tissue Act, and Data Protection Regulation.
  • Quality Assurance Leadership: Provide guidance and leadership on quality assurance, overseeing day-to-day operations, and fostering a culture of quality and compliance within the organization.
  • Pharmacovigilance and Risk Management: Lead the development and implementation of highly effective pharmacovigilance reporting and oversight systems to ensure the safe conduct of all clinical trials.
  • Study Planning and Protocol Development: Collaborate with researchers to ensure that all aspects of regulations have been considered in the planning of new clinical research studies and trials, providing advice on protocol development and associated documents.
  • Project Management and Training: Support the clinical trial manager in crafting and delivering 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.
Requirements
  • Education and Qualifications: Educated to degree level or equivalent, with evidence of professional CPD.
  • Quality Assurance Experience: Proven experience and knowledge of working within clinical trial legislative frameworks, including Clinical Trials involving Investigational Medicinal Products (CTIMPs).
  • Industry Experience: Experience of working in a Higher Education environment, with a risk-based approach to management and conduct of clinical trial activities.