Quality System Manager

Looking for a Quality Systems Manager to join an Oncology focused Biotechnology company based in Oxford.Purpose:Provide coordination and management in the operation of the Quality Management System (QMS).Act as the main point of contact for the business in matters relating to the operation of the QMS.To ensure compliance to regulatory requirements, internal polices, Standard Operating Procedures and standards in the operation of the QMS.To help ensure continuous improvement of the QMS.Experience:At least 2 years’ experience in the operation of quality systems in a pharmaceutical quality related role. Experience of working within sterile pharmaceutical manufacturing and/or radiopharmaceutical manufacturing is desirable but not essential.Duties:Administration and management of the eQMS, document management and learning management systems.Development and generation of metrics, measures and reports for the operation of the QMS.Oversight and coordination, to ensure the quality and timely management of:Change controls / Deviations / CAPAs / Product Quality Reviews / Complaints / Self-inspectionQuality Risk RegisterAuthor and implement QMS proceduresPreparation and management of finished product labelling and patient information leafletsPlan and conduct internal audits and self-inspectionsProvide advice and encouragement to staff to ensure individual and company complianceProvide training to staff on general or specific quality topicsSupport the QA team in relation to quality investigations and initiativesPrepare, manage and present materials for Quality Management ReviewContribute to continuous improvement activities and take ownership of continuous improvement tasks and projects.Skills and Competencies:Proactive approach and can-do attitudeExcellent written, verbal and presentation skillsExcellent organisational skillsExcellent IT skills for standard desk top packages (experience with Power BI desired but not essential)Good analytical skillsCompetent in problem solving, team building, planning and decision makingSound knowledge of GMP and/or GCPQualifications:A degree in a science related discipline.Reporting to:Associate Director, Quality Operations.Flexible working available with the requirement to be onsite twice a week.