Biosamples & Human Tissue Act Lead

Your new company

You'll be joining a global pharmaceutical company supporting a major laboratory and research facility transition. You will play a pivotal role in ensuring Human Tissue Act (HTA) compliance throughout the establishment of a new satellite site and the transfer of regulated human tissue samples.

Your new role

As a Biosamples and Human Tissue Specialist, you will provide expert guidance on the creation of a new HTA-compliant satellite site while ensuring continuity of compliance throughout a large-scale sample relocation programme.

This is a 12 month contract that can either be full-time or part-time (minimum 3 days per week).

Key responsibilities include

• Providing expert advice on the establishment and approval of a new HTA satellite site
• Supporting the development of accurate inventories and governance processes for HTA-regulated material
• Advising on the transfer, storage, and management of human tissue samples throughout the relocation programme
• Ensuring compliance with Human Tissue Act 2004 requirements, licence obligations, and associated governance processes
• Providing guidance on the transportation of human tissue as dangerous goods
• Reviewing and updating HTA procedures, SOPs, and operational processes to ensure suitability for the new facility
• Preparing the satellite site for internal and external HTA inspections and supporting ongoing compliance activities

What you'll need to succeed

A successful candidate will bring deep expertise in HTA compliance, human tissue governance, and regulated sample management:

• Extensive experience working under the Human Tissue Act (HTA) 2004
• Strong understanding of HTA licensing, inspections, governance, and compliance requirements
• Experience establishing, managing, or supporting HTA-licensed facilities or satellite sites
• Knowledge of the transportation and handling of human tissue samples, including dangerous goods requirements
• Experience reviewing and implementing HTA SOPs, quality systems, and compliance frameworks
• Strong stakeholder management skills, with the ability to advise senior leaders and project teams
• Ability to combine strategic oversight with occasional hands-on support where required

The following would be an advantage but are not essential

• Previous experience supporting laboratory relocations or site transitions
• Experience preparing sites for HTA inspections
• Background within pharmaceutical, biotechnology, clinical research, or human tissue banking environments

ALL candidates must hold the right to work in the UK without sponsorship until at least October 2027. Candidates without this will not be considered.

What you'll get in return

As well as flexibility in how you work, you'll be supporting a significant HTA-regulated facility transition by providing strategy and advice as well as hands-on input to support a diverse and highly experienced team.

There is also a generous day rate on offer.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

Keywords

HTA, Human, Tissue, Compliance, Governance, Regulatory, Pharmaceutical, Biotechnology, Licence, Inspection, Satellite, Relocation, Transfer, Storage, Samples, Biobank, Pathology, Quality, SOPs, Audit, Dangerous, Goods, Transport, Validation, Facilities, Research, Laboratory, Risk, Documentation, Operations