Role DescriptionThis is a full-time on-site/hybrid role for a Manager of Quality Services based in our stunning headquarters in Hartley Wintney, Hampshire. TMC is a CRO specialising in Rare and Orphan Diseases. As a Manager of Quality Services, you will be a key member of the TMC in-house team reporting to the Associate Director of Quality Assurance.Essential Skills and ExperienceStrong knowledge of ICH GCP and relevant regulations (EMA, MHRA).GCP certification within the last 2 yearsMinimum of 5 years prior experience in an Audit/QA function of the Pharmaceutical/pharmaceutical service Industry (CRO)Familiarity with quality systemsBachelor’s degree in a related fieldResponsibilitiesmanaging TMC’s Quality Management System,for providing QA guidance and oversight to the TMC team and Clients,hosting Client audits,supporting the delivery of TMCs Internal and Vendor Audit Program andfor QI and CAPA management.You will get the opportunity to work on a wide range of quality activities in some very interesting disease/treatment areas, and to further develop your skills.Other skillsOther GxP knowledge and experience would be desirableExperience of Process Management (authoring, reviewing, approving SOPs and associated controlled documents) would be of benefitExperience of FDA regulatory environment desirableExperience of requirements of MAH/GMP desirableExcellent analytical and problem-solving skillsAbility to work effectively in cross-functional teamsExceptional attention to detailExcellent written and verbal communication skillsStrong organisational and time management skillsAdvanced degree in a related field is a plus
