Hobson Prior are in search for a Quality and Standards Manager to support the ATTC network and industry in the execution of projects to drive quality-based standardisation and best practice. You will join a leading organisation focused on advancing the growth of cell and gene therapy research across the UK, helping to promote the use of these therapies throughout the health services all over the world.

Job Responsibilities:

• You will work with counterparts across Accelerated Access Collaboratives and ATTCs to deliver a number of standardisation initiatives using pioneering solutions, wherever possible.
• Accountable to help develop Companion Diagnostics standards to accelerate the adoption of ATMP, using exemplar products to test the system.
• Engage with existing ATMP manufacturers, supporting industry partners and the NHS to identify opportunities and challenges and jointly agree way forward.
• Develop the work of the SAMPLE Standard Approach to ATMP tissue collection) group of ATTC to drive the standardisation work on starting material procurement, handling, transport, labelling, delivery process etc.
• Co-operate with international bodies to develop international standards suitable for use in the NHS and globally.
• Work with Regulators to ensure the work meets regulatory requirements.
• Develop strategies for optimisation of harmonisation of practices to appropriate quality and regulatory standards.
• Assess potential for cross-linking and interoperability with other relevant data sources to address evidence gaps / validate quality of evidence.
• Develop and implement a 20-month workplan than enables the implementation of the above optimisation strategies.
• Work and engage with the following stakeholders: NHS (e.g. ATTC, Cell Laboratories, Blood Services, Pharmacies, clinical trial units, Accelerated Access Collaborative, etc), industry bodies (e.g. ABPI, ARM, BIA, SCB, UKSLGAT) and regulators.

Key Skills:

• Ability to present highly complex and sensitive or contentious information.
• A flexible approach to work assignments with an ability to manage multiple and varied tasks and to prioritise the workload whilst maintaining attention to details.
• Analytical and conceptual thinking skills.
• Capability to influence senior stakeholders and to work closely with them to determine acceptable solutions.
• Able to work quickly and accurately, with limited supervision.

Requirements:

• Degree level educated in a Life Science or related discipline.
• A minimum of 5+ years' experience of relevant ATMP development and supply from a quality or manufacturing viewpoint.
• Understanding of the quality and regulatory requirements for ATMP manufacture and supply.
• Experience of supply of Medical Products into the NHS, either from starting material procurement, clinical trial and marketed product delivery.
• Experience in running multi stakeholder projects.
• Understanding of the NHS.
• Experience of PowerPoint presentations and generating Executive/Board reports.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.