Bio-Sample Quality Lead (12 month FTC)

Our Future Health; London; On-site; GBP 55,000 - 62,000; Full time

Job summary

A leading health research program in the UK is seeking a Bio-Sample Quality Lead to oversee the quality of samples collected. This role involves managing quality systems, ensuring compliance with standards, and collaborating with various teams. The ideal candidate will have a life sciences degree and laboratory experience, along with strong problem-solving and communication skills. Join us to contribute to disease prevention efforts.

Benefits

Generous pension scheme

30 days holiday plus bank holidays

Enhanced parental leave

Career development budget

Cycle to Work scheme

Home & Tech savings

Employee referral bonus

Wellbeing support

Flexible working options

Qualifications

• Laboratory experience including sample processing and analysis.
• Experience with biobanks and QA/QC procedures.

Responsibilities

• Maintain a high-quality biobank and database of research samples.
• Drive activities to ensure compliance with ISO standards.
• Produce quality reports for internal and external stakeholders.

Skills

Attention to detail

Problem-solving

Communication

Interpersonal skills

Numeracy

Analytical skills

Education

Life sciences degree

Tools

Sample management software

Job description

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 setup and management of all operational aspects of the Our Future Health cohort, which includes recruiting 5 million participants and collecting their data and biological samples in line with the programme's budget and timelines.

As the Bio-Sample Quality Manager, you will oversee the quality of all samples collected for Our Future Health. This includes developing, implementing, and improving a sample quality management system in collaboration with suppliers and internal teams.

About Our Future Health:

It is the UK’s largest health research programme, aiming to develop new methods to detect, prevent, and treat diseases. Supported by the UK Government and in partnership with charities and industry, it works closely with the NHS and public authorities across the UK.

Key Responsibilities:

1. Maintain a high-quality biobank and database of research samples.
2. Oversee daily sample and package reconciliation tasks, investigating quality incidents as needed.
3. Manage the Bio-Sample Incident Management board, ensuring timely logging and resolution of incidents.
4. Line manage and develop the Bio-Sample Operations Assistant.
5. Monitor sample handling effectiveness across all stages, including collection, fractionation, DNA extraction, and genotyping.
6. Drive activities to ensure compliance with standards like ISO 15189, ISO 9001, ISO 13485, and HTA regulations.
7. Maintain and improve quality control documentation related to bio-samples for internal and external dissemination.
8. Collaborate with product, technology, and data teams to develop a robust sample management software tool.
9. Work with external partners and conduct audits to verify compliance and identify improvements.
10. Produce quality reports for internal and external stakeholders.
11. Ensure sample quality aligns with scientific requirements.
12. Participate in internal quality forums and coordinate incident management with the Head of Quality.
13. Write and review non-compliance and deviation reports; develop CAPA plans for risk mitigation and process improvement.
14. Oversee supplier quality performance with the contract management team.
15. Lead meetings on sample quality management and best practices.
16. Assist in designing and improving bio-sample workflows.
17. Support onboarding of laboratories and setup of new clinics.

Required Skills and Experience:

• Life sciences degree or equivalent experience.
• Laboratory experience, including sample processing and analysis.
• Knowledge of UK clinical research environment, including sample handling and storage.
• Experience working with external partners and suppliers.
• Understanding of GCP, HTA, ISO 15189, ISO 9001 standards.
• Experience with biobanks and QA/QC procedures, including SOP writing.
• Familiarity with sample management software tools.
• Willingness to attend site visits.
• Experience in writing reports and developing CAPA plans.
• Ability to conduct quality audits.
• Attention to detail, problem-solving skills, and strong communication and interpersonal skills.
• Ability to multitask, organize, and work independently with high motivation.
• Numeracy and analytical skills.

Benefits:

• Up to £62,000 salary.
• Generous pension scheme with up to 12% employer contributions.
• 30 days holiday plus bank holidays.
• Enhanced parental leave.
• Career development budget and opportunities.
• Cycle to Work scheme.
• Home & Tech savings.
• Employee referral bonus of £1,000.
• Wellbeing support including mental health services and online GP.
• Flexible and remote working options, with a central London office in Holborn.

Join us — let’s prevent disease together.