Quality urance Manager

As QA manager you will be responsible forensuring that all aspects of the work conducted by the respectiveunits adheres to regulatory requirements industry standards andLSTM policies. You will play a critical role in maintaining theintegrity reliability and quality of our clinical trialoperations.
Additional responsibilities will includeimplementing and maintaining the Quality Management Systems (QMS)including but not limited to quality assurance processes stafftraining risk management andmonitoring.

Your responsibilitieswillinclude:

• Managementof Quality Management System (QMS) ensuring alignment with relevantregulatory guidelines including ICHGCP country specific regulationsHuman Tissue Act and Data ProtectionRegulation.
• Providing leadership and guidanceon quality assurance overseeing daytoday operations and fostering aculture of quality and compliance within theunits.
• Supporting the Trial Teams to ensure thesafe conduct of all clinical trials though leadership of highlyeffective pharmacovigilance reporting and oversightsystems.
• Leading the quality function inassisting researchers in planning new clinical research studies andtrials to ensure that all aspects of the regulations have beenconsidered; provide advice on development of protocol andassociated documents.
• Supporting the clinicaltrial manager to craft and deliver clinical research projectsagainst agreed project achievements and qualitystandards.
• Coordinating the design and deliveryof training necessary to ensure high standards and regulatorycompliance across all staff groups working on the clinical researchportfolio. This includes leading development of specific trainingaccording to demand.

Qualifications andskillsrequired:

• Educatedto Degree Level or equivalent.
• Evidence ofprofessional CPD.
• Quality Assurancequalification or equivalent relevantexperience.
• Experience and knowledge of workingwithin clinical trial legislative frameworks including ClinicalTrials involving Investigational Medicinal Products(CTIMPs).
• Experience of working in a HigherEducation environment.
• Experience of ariskbased approach to management and conduct of clinical trialactivities.

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RemoteWork :

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