Compliance Officer at Awerian Ltd

Cambridge, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

02 Jun, 26

Salary

0.0

Posted On

04 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Compliance Strategy, ISO 9001, ISO 13485, GxP Expectations, ESG Requirements, Risk Management, Auditing, Validation, Data Integrity, QMS, Policy Development, Training Delivery, Regulatory Interpretation, Product Certification, Engineering Collaboration

Industry

Defense and Space Manufacturing

Description

Company Description Cell therapies have been shown to cure devastating diseases like cancer by reprogramming a patient’s own immune system, offering hope where there was none before. Giving more patients access to these life-saving therapies requires a revolution in manufacturing and process automation. Cellular Origins is leading this revolution. Our proprietary technology tackles the challenges of large-scale production with an elegant robotic automation system that cuts costs, reduces labour, eliminates human error, and boosts efficiency. Job Description As our Compliance Officer, you’ll lead the regulatory and compliance strategy across the business, making sure our technology, systems, and ways of working meet global regulatory expectations without slowing down innovation. You’ll give our teams the confidence that what they are building is not only technically brilliant, but also compliant, auditable, and ready to support therapies at commercial scale. This role acts as a bridge between regulation and engineering. You’ll translate complex requirements into clear, workable guidance that supports the development and deployment of our cell and gene therapy manufacturing equipment. You’ll collaborate closely with teams across engineering, product, operations, and leadership, providing clear visibility of compliance risks and practical mitigation plans. You’ll help us build a compliance function that feels like an enabler, not a brake, so people seek you out early, rather than only when there is a problem. This will be an on-site based role at our campus in Melbourn, Cambridgeshire. What you’ll do You’ll get to shape how compliance works at Cellular Origins, embedding it into daily decisions, not just documentation. You’ll design the frameworks, policies, and training that keep us aligned to standards, while still giving our engineers room to innovate. Lead the development and ongoing management of our regulatory and compliance strategy across the business, covering ISO 9001, ISO 13485, GxP expectations and ESG requirements. Map applicable regulations, standards and ESG frameworks to our technology and operations, turning them into clear internal policies, governance processes and pragmatic guidance. Own and evolve internal policy and governance, ensuring decisions are aligned with compliance requirement. Partner with engineering and product teams to embed “compliance by design” into equipment, automation and software, including validation, documentation and data integrity expectations. Run compliance risk management from a regulatory perspective, maintaining risk registers, defining mitigations, and giving leadership a clear line of sight to key issues. Support and, where appropriate, lead internal and external audits, coordinating responses and managing remediation actions through to closure. Provide operational compliance support to teams across the business. Design and deliver training, communications and mentoring that build a strong compliance culture, so people understand not just what to do, but why it matters for patients. Qualifications You enjoy sitting at the intersection of regulation, engineering and operations. You are as comfortable in a technical discussion about validation as you are explaining a new policy to a cross-functional audience. You’ll bring: A Master’s degree in Regulatory Affairs, Biomedical Engineering, Biotechnology, Quality Management, or a related field. Experience in a regulated industry, such as medical devices, ATMPs, biopharma manufacturing, or regulated automation systems. Demonstrated experience applying ISO 9001 and/or ISO 13485 and GxP in practice, not just awareness on paper. Knowledge of FDA regulatory expectations and how they interact with ISO and GxP requirements. Strong QMS experience, including supporting or running audits (internal and external) and managing remediation actions. Experience working directly with engineering and technical teams on validation, documentation, and compliance alignment for equipment and software. Compliance risk management experience in regulated equipment environments. Confidence in regulatory interpretation for engineering systems, including but not limited to automation, software and data integrity. Experience engaging with ESG requirements in a practical, operational context. Desirable Experience with product certification (for example CE, UKCA or equivalent routes to market). Experience in high-growth or scaling environments, where frameworks and policies need to grow with the organisation. Additional Information Cellular Origins is based on the TTP Campus, within purpose-built sustainable offices, labs and green surroundings, 10 miles south of Cambridge. Our working culture encourages entrepreneurship, shared ideas and collaboration, while providing you the freedom to do your best work. Our employee benefits include: Annual 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 Activities and community 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! Role Type: Experienced Contract Type: Permanent Technical Discipline: Specialist Department: Cellular Origins

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Responsibilities

The Compliance Officer will lead the regulatory and compliance strategy across the business, ensuring technology, systems, and operations meet global regulatory expectations while enabling innovation. This involves designing frameworks, policies, and training, and embedding compliance into daily engineering and product decisions.