Quality Assurance Manager

1 week ago


Liverpool, Liverpool, United Kingdom Lifelancer Full time
Job Title: Quality Assurance Manager

As a Quality Assurance Manager at Lifelancer, you will play a critical role in ensuring the integrity, reliability, and quality of our clinical trial operations. Your responsibilities will include:

Key Responsibilities:
  • Quality Management Systems (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 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.
  • Study Planning and Protocol Development: Assist researchers in planning new clinical research studies and trials, ensuring all aspects of regulations have been considered, and provide advice on protocol development and associated documents.
  • 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.
Requirements:
  • Education: Educated to Degree Level or equivalent.
  • Professional Development: Evidence of professional CPD.
  • Quality Assurance Qualification: Quality Assurance qualification or equivalent relevant experience.
  • Clinical Trials 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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