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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:- 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 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.
- 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.
- Education: 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.
Lifelancer is a talent hiring platform in Life Sciences, Pharma, and IT. The platform connects 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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