Job Description

Company Description

Cell therapies have been shown to cure devasting and previously untreatable diseases like cancer by re-programming the patient's own immune system. Giving more patients access to these life-saving therapies requires a revolution in manufacturing and process automation.


Cellular Origins, a TTP Company, is enabling scalable, cost-effective and efficient manufacture of cell and gene therapies. Our technology addresses the challenges associated with manufacturing at scale with an elegant robotic manufacturing automation solution that reduces cost and labour, eliminates human error, and increases efficiency.

In this role you will work closely with our Quality Manager and will be responsible for managing and maintaining the Quality Management System (QMS) to ensure compliance with applicable standard (ISO 9001).


Cellular Origins are currently in the process of obtaining ISO 9001, this role will be to support the Quality Manager and the wider business with completing necessary steps to achieve this. Part of the role will be to support continuous improvement initiatives, ensure document and record control management, and get involved with internal and external audits.


You will administer and maintain the electronic Quality Management System (eQMS), you will manage the document control processes, including review, revision and archiving of quality documents where and when necessary (SOPs, WI, forms).

Develop and provide training to QMS.. Oversee that training records are maintained. Ensure system compliance with quality standards and applicable regulations. Support audit readiness by maintaining accurate and up-to-date records. Assist with internal and regulatory audits. Track and report on quality metrics (e.g., CAPAs, NCRs, training compliance). Coordinate and monitor corrective and preventive action (CAPA) processes. Collaborate with cross-functional teams to drive continuous improvement. Support risk management activities and change control processes.

Qualifications

Essential:

Experience in a regulated industry (e.g., medical devices, pharmaceuticals, healthcare, finance, engineering: environment, aerospace or automotive for example). Experience working with Quality or Business Management System environment and ISO standards. Proficient in eQMS platforms Experience of the entire audit process. Strong organisational and documentation skills. Strong attention to detail with excellent problem-solving abilities. Proficient in Microsoft Office Suite. Ability to manage multiple tasks and prioritise effectively. This role will be a full time on-site position at our campus in Melbourn.

Desirable:

Experience working with collaboration tools (e.g. JIRA, Confluence). Knowledge of ISO 9001, ISO 13485 Internal auditor certification. Knowledge in Cognidox/Sharepoint)

Additional Information

Cellular Origins is part of TTP Group, an employee-owned business. It is based on the TTP Campus, within purpose-built sustainable offices, labs and green surroundings, 10 miles south of Cambridge. TTP Group takes a long-term approach to investment and has been at the forefront of bioprocess automation for over 20 years. Our working culture encourages entrepreneurship, shared ideas and collaboration, while providing you the freedom to do your best work.


Our employee benefits include:

Annual profit-related bonus 25 days holiday Employer pension contribution of 10% of salary Free lunch and all-day refreshments Private medical insurance for employees and dependants Enhanced family friendly leave Life insurance worth 6x salary Electric car leasing scheme Cycle to work scheme Season ticket loan An activities and community fund that supports healthy activities that bring colleagues together; whether it's lunchtime squash or football, Zumba or our own rock band. Colleagues initiate new clubs and outings whenever they feel there's something missing! * Local sports facilities and theatre discounts and memberships.