Quality Assurance Manager

As QA manager, you will be responsible for ensuring that all aspects of the work conducted by the respective units adheres to regulatory requirements, industry standards, and LSTM policies. You will play a critical role in maintaining the integrity, reliability, and quality of our clinical trial operations.
Additional responsibilities will include implementing and maintaining the Quality Management Systems (QMS), including but not limited to quality assurance processes, staff training, risk management and monitoring.

Your responsibilities will include:

• Management of Quality Management System (QMS), ensuring alignment with relevant regulatory guidelines including ICH-GCP, country specific regulations, Human Tissue Act and Data Protection Regulation.
• Providing leadership and guidance on quality assurance, overseeing day-to-day operations and fostering a culture of quality and compliance within the units.
• Supporting the Trial Teams to ensure the safe conduct of all clinical trials though leadership of highly effective pharmacovigilance reporting and oversight systems.
• Leading 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.
• Supporting the clinical trial manager to craft and deliver 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 working on the clinical research portfolio. This includes leading development of specific training according to demand.

Qualifications and skills required:

• 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.

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