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Quality Assurance Manager
2 months ago
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. You will be responsible for implementing and maintaining the Quality Management Systems (QMS), including quality assurance processes, staff training, risk management, and monitoring.
Key Responsibilities:- Lead the development and implementation of QMS policies and procedures to ensure compliance with regulatory guidelines, including ICH GCP, country-specific regulations, Human Tissue Act, and Data Protection Regulation.
- Provide leadership and guidance on quality assurance, overseeing day-to-day operations and fostering a culture of quality and compliance within the organization.
- Support the Trial Teams to ensure the safe conduct of all clinical trials through leadership of highly effective pharmacovigilance reporting and oversight systems.
- Collaborate with researchers to plan new clinical research studies and trials, ensuring that all aspects of regulations have been considered, and provide advice on the development of protocols and associated documents.
- Support the clinical trial manager in crafting and delivering clinical research projects against agreed project achievements and quality standards.
- 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.
- Educated to Degree Level or equivalent.
- Evidence of professional CPD.
- Quality Assurance qualification or equivalent relevant experience.
- Experience and knowledge of working within clinical trial legislative frameworks, including Clinical Trials involving Investigational Medicinal Products (CTIMPs).
- Experience of working in a Higher Education environment.
- Experience of a risk-based approach to management and conduct of clinical trial activities.
Lifelancer is a talent hiring platform in Life Sciences, Pharma, and IT. We connect talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains. Please use the below Lifelancer link for job application and quicker response.
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