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    Quality Manager - Cambridge, United Kingdom - Cellular Origins

    Cellular Origins
    Cellular Origins Cambridge, United Kingdom

    1 week ago

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    Description
    Job Description

    Cellular Origins

    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. Cellular Origins' 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.

    We're now looking for a Quality Manager with experience leading a start-up through to ISO 9001 (or similar) to join our mission.

    Quality Manager

    As our Quality Manager you'll come in to build and implement Cellular Origins' Quality Management System (QMS), ensuring it adapts continuously to our evolving business needs. Your mission? To establish a fitting approach to quality throughout every stage of development and manufacture, driving continuous improvement and leaving little room for error.

    You'll be guiding the internal teams to embrace the evolving QMS as second nature. You'll seek collaborative input on validation plans and will lead quality training throughout the business. As part of your mission to implement our QMS, you'll set up and manage a version-controlled digital document management system.

    You'll be in a customer-facing role, managing both in-person and virtual customer audits. Customer relationships are key – through your engagement with both current and potential customers you'll ensure our systems are tailored to align with their quality and regulatory requirements. Plus, you'll uphold supplier quality through audit, helping our suppliers close any gaps and developing their capabilities.

    Attention to detail and process is where you're strongest, but you're also able to work flexibly and pragmatically in support of fast progress. You'll be comfortable as part of a fast-growing, dynamic team of engineers and scientists, demonstrating the ability to collaborate, as well as work independently, where needed. As we grow, so may our QM need, and we expect you to own the strategy in building quality-focused resources.

    Whilst it's not your main priority, you may want to contribute directly to our system development work through, for example, FMEA activities, manufacturing process development, design-for-manufacture or assembly activities. Your breadth and depth of impact on the business will be guided by your experience and aspirations to develop alongside your core Quality Manager responsibilities.

    Requirements

    • A bachelor's or master's degree in a STEM discipline
    • Experience of leading a company through to ISO9001/13485 in a development and manufacturing environment
    • An awareness of the requirements of GMP manufacture of biological products
    • Experience leading the establishment, maintenance and development of a QMS
    • Experience of managing customer and supplier audits
    • The ability to influence, train and mentor colleagues to ensure a 'Quality' culture.
    • Clear and concise written communication skills
    • A rigorous approach to work with a strong eye for detail
    • Comfortable adapting to new software tools and equipment, as required
    • Excellent collaboration skills, with the ability to work effectively in interdisciplinary teams and fast-paced environments.
    • Evidenced skills in change management, ideally gained through implementation of QMSs.

    The above list outlines our ideal candidate, but we know some of you may not apply unless you qualify for all requirements. We believe in the power and importance of diversity, both for our community and the success of our business, so please apply if you meet most of our listed capabilities.

    Company Info and Benefits

    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 12% of pensionable pay
    • 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.
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