Compliance Officer
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Job Location:
Monthly Salary:
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
As our Compliance Officer youll 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. Youll 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. Youll translate complex requirements into clear workable guidance that supports the development and deployment of our cell and gene therapy manufacturing equipment. Youll collaborate closely with teams across engineering product operations and leadership providing clear visibility of compliance risks and practical mitigation plans.
Youll 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 youll do
Youll get to shape how compliance works at Cellular Origins embedding it into daily decisions not just documentation. Youll 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.
Youll bring:
- A Masters 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 its lunchtime squash or football Zumba or our own rock band. Colleagues initiate new clubs and outings whenever they feel theres something missing!
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Compliance Management
- Risk Management
- Financial Services
- PCI
- Banking
- Cost Accounting Standards
- Quality Systems
- Research Experience
- NIST Standards
- Securities Law
- SOX
- ISO 27000
About Company
Cell therapies have shown the ability to cure the incurable and yet we cannot get them to patients because of an inability to scale manufacturing. The Cellular Origins team is transforming patient access to cell therapies by addressing the challenges associated with scalable, cost-eff ... View more
