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.

REQUIREMENTS

To succeed in this role, you will also have some of the following skills:

• Life sciences degree or equivalent experience.
• Proven 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 skills.
• Excellent understanding and experience of Good Clinical Practice (GCP), Human Tissues Act (HTA), ISO 15189 and ISO 9001
• Proven experience working with a sample biobank.
• Previous 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 tools.
• Available to attend laboratory and clinic site visits as required.
• Experience of writing non-compliance and deviation reports and developing CAPA plans.
• Experience of conducting quality audits.
• Excellent attention to detail and problem-solving skills.
• Strong interpersonal and team working skills, with the ability to effectively interact with people at all levels.
• Proven 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 independently.
• A high level of numeracy, analytical, and interpretive skills.

WHAT YOU’LL BE DOING:

Your key responsibilities will include but not be limited to:

• Maintain a high-quality biobank and database of research samples.
• Oversee daily sample and package reconciliation tasks and investigate quality incidents where required.
• Oversee Bio-Sample Incident Management board, ensuring all incidents are logged and addressed in a timely manner.
• Line management and development of the Bio-Sample Operations Assistant.
• Monitor 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 Genotyping.
• Drive 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 regulations.
• Develop, 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 tool.
• Work closely with appropriate external partners at laboratories and clinics and conduct audits where required, to verify compliance with requirements and highlight opportunities for improvement.
• Produce quality reports for dissemination to external suppliers and internal stakeholders to support key business decisions.
• Work with the Science team to ensure sample quality and operations meet the scientific requirements of the Our Future Health project.
• Participate 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 timelines.
• Lead regular meetings to report on sample quality management and advise on best practice.
• Assist with the bio-sample workflow design and its continuous improvement.
• Assist with the onboarding of laboratories and set-up of new clinic locations.

To succeed in this role, you will also have some of the following skills:

• Life sciences degree or equivalent experience.
• Proven 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 skills.
• Excellent understanding and experience of Good Clinical Practice (GCP), Human Tissues Act (HTA), ISO 15189 and ISO 9001
• Proven experience working with a sample biobank.
• Previous 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 tools.
• Available to attend laboratory and clinic site visits as required.
• Experience of writing non-compliance and deviation reports and developing CAPA plans.
• Experience of conducting quality audits.
• Excellent attention to detail and problem-solving skills.
• Strong interpersonal and team working skills, with the ability to effectively interact with people at all levels.
• Proven 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 independently.
• A high level of numeracy, analytical, and interpretive skills