Bio-Sample Quality Lead (12 month FTC) (Basé à London)

2 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.We have an exciting opportunity for a Bio-Sample Quality Lead to work within the Clinical Operations team. The team is responsible for the overall set up and management of all operational aspects of the Our Future Health cohort which includes recruitment of 5 million participants and the collection of their data and biological samples in line with the overall programme budget and timelines.As the Bio-Sample Quality Manager you will oversee the quality of all samples collected for Our Future Health. This will include the continuing development, implementation and improvement of a sample quality management system working in collaboration with suppliers and internal teams.Our Future Health will be the UK\’s largest ever health research programme, bringing people together to develop new ways to detect, prevent, and treat diseases. We are a charity, supported by the UK Government, in partnership with charities and industry. We work closely with the NHS and with public authorities across all nations and regions of the UK.What you\’ll be doing:Your key responsibilities will include but not be limited to:Maintain a high-quality biobank and database of research samplesOversee daily sample and package reconciliation tasks and investigate quality incidents where requiredOversee Bio-Sample Incident Management board, ensuring all incidents are logged and addressed in a timely mannerLine management and development of the Bio-Sample Operations AssistantMonitor effectiveness of sample handling at all points of the journey to ensure consistently high-quality samples are obtained. Including, but not limited to, sample collection, fractionation, DNA extraction and GenotypingDrive quality management system activities to ensure supplier and organisational compliance with applicable bio-sample standards such as ISO 15189, ISO 9001, ISO 13485 and HTA regulationsDevelop, maintain, and improve all quality control documentation relating to bio-samples (including handling, transport, processing, storage) ready for dissemination both internally and externally.Collaborate with Our Future Health colleagues within the product and technology & data teams to develop a robust sample management software toolWork closely with appropriate external partners at laboratories and clinics and conduct audits where required, to verify compliance with requirements and highlight opportunities for improvementProduce quality reports for dissemination to external suppliers and internal stakeholders to support key business decisionsWork with the Science team to ensure sample quality and operations meet the scientific requirements of the Our Future Health projectParticipate in internal Quality Forum to discuss organisational quality and liaising with Head of Quality and Management Systems to coordinate sample incidents that impact multiple internal departments.Write and review non-compliance & deviation investigation reports and create CAPA plans as required, providing support in risk mitigation, planning corrective/preventive actions and guidance for improvement.Work with contract management team to oversee supplier quality performance, to ensure samples are received, assayed and data is reported according to study timelinesLead regular meetings to report on sample quality management and advise on best practiceAssist with the bio-sample workflow design and its continuous improvement.Assist with the onboarding of laboratories and set-up of new clinic locationsRequirementsTo succeed in this role, you will also have some of the following skills:Life sciences degree or equivalent experienceProven experience working within a laboratory setting, including processing and/or analysis of samples.Working knowledge of the UK clinical research environment, including appropriate sample collection, handling, and storage procedures.Experience working with external partners and suppliers, demonstrating excellent diplomacy skillsExcellent understanding and experience of Good Clinical Practice (GCP), Human Tissues Act (HTA), ISO 15189 and ISO 9001Proven experience working with a sample biobankPrevious experience of devising and implementing Quality Assurance and Quality Control procedures related to collection, handing and storage of bio-samples for research (including writing SOPs)Previous experience with sample management software toolsAvailable to attend laboratory and clinic site visits as requiredExperience of writing non-compliance and deviation reports and developing CAPA plansExperience of conducting quality auditsExcellent attention to detail and problem-solving skillsStrong interpersonal and team working skills, with the ability to effectively interact with people at all levelsProven ability to multi-task with excellent organisational and time management skills.Strong written and verbal communication skills.Highly motivated with a proactive approach to work and ability to work independentlyA high level of numeracy, analytical, and interpretive skills.BenefitsUp to £62,000 per annum basic salaryGenerous Pension Scheme – We invest in your future with employer contributions of up to 12%30 Days Holiday + Bank Holidays – Enjoy a generous holiday allowance with the flexibility to take bank holidays when it suits youEnhanced Parental Leave – Supporting you during life\’s biggest momentsCareer Growth & Development – £500 per year to spend on Learnerbly, our learning platform, plus regular appraisals and development opportunitiesCycle to Work Scheme – Save 25-39% on a new bike and accessories through salary sacrificeHome & Tech Savings – Get up to 8% off on IKEA and Currys products, spreading the cost over 12 months through salary sacrifice£1,000 Employee Referral Bonus – Know someone amazing? Get rewarded for bringing them on board!Wellbeing Support – Access to Mental Health First Aiders, plus 24/7 online GP services and an Employee Assistance Programme for you and your familyA Great Place to Work – We have a lovely Central London office in Holborn, and offer flexible and remote working arrangementsJoin us – let\’sprevent disease together.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeContractJob functionJob functionQuality AssuranceIndustriesIT Services and IT ConsultingReferrals increase your chances of interviewing at Our Future Health UK by 2xGet notified about new Quality Lead jobs in London, England, United Kingdom.London, England, United Kingdom 1 month agoLondon, England, United Kingdom 2 days agoHead of Quality Improvement and AssuranceLondon, England, United Kingdom 3 weeks agoKingston Upon Thames, England, United Kingdom 1 week agoDirector, Country Head Quality Assurance – UK & IrelandLondon, England, United Kingdom 1 week agoLondon, England, United Kingdom 3 days agoLondon, England, United Kingdom 2 months agoGreater London, England, United Kingdom 1 month agoQuality and Compliance Manager (Pharmareview)London, England, United Kingdom 2 weeks agoBrentwood, England, United Kingdom 2 weeks agoHead of Quality – Design (Director Level)Greater London, England, United Kingdom 1 day agoLondon, England, United Kingdom 3 days agoWe’re unlocking community knowledge in a new way. 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