Location: White City, London
At Quell we seek to deliver truly innovative, life-changing therapies for our patients. Our vision as a company is to build a major global biopharmaceutical company bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.
Quell was founded in March 2019 in partnership with six prominent immunological experts from King’s College London, University College London, and Hannover Medical School, and is led by Iain McGill, a leading pharmaceutical executive with extensive relevant experience, having spent most of his 25 years in the industry in immunology, including the areas of solid organ and cell transplantation. The Company was founded with initial series A financing, led by Syncona Ltd who committed £34M with a further £1M contributed by UCL Technology Fund.
Quell is looking for a QA Associate to provide Quality support for Quell manufacturing operations across Quell’s GMP licensed facilities (London and Stevenage). This position offers an excellent opportunity for an innovative and pragmatic quality professional to contribute to developing a risk-based quality system which supports the development of a growing pipeline of assets in an exciting and highly dynamic environment focused on developing cutting-edge cellular therapies.
- Assist in the development of the Quell PQS
- Support in routine QA duties to ensure manufacturing and testing activities comply with the local GMP facility processes where products are manufactured
- Provide quality support to ensure starting materials are procured, tested and imported as required according to UK HTA requirements
- Work closely with the QA Managers perform day to day duties as required by the following elements of the PQS relating to manufacture and testing of cellular therapies including;
- document control system
- training system
- change controls
- corrective and preventative actions (CAPA)
- deviation & OOS reporting
- quality risk management
- qualification & validation
- internal audits
- vendor qualification
- batch record review prior to QP release
- product specification files for ATIMP’s
- Draft, review and approve Quality and GxP related documentation
- Advise the Quell manufacturing and QC teams on Quality related issues
- Inform Head of Quality, Senior members of the QA team and Senior Management of significant quality related matters or risks that could impact patient safety, product quality, product release or regulatory compliance
- Produce KPI’s and quality metrics
- Provide Quality support for other areas of the business e.g. R&D, process and analytical development processes in Quell’s state of the art R&D laboratories to ensure best laboratory and data integrity practices
- Promote quality culture and one of continuous improvement within team
ESSENTIAL SKILLS AND EXPERIENCE
- University degree in a biological science, chemistry or equivalent
- Experience in GMP manufacturing environment (in particular small scale e.g. ATMP’s, clinical trials or individualised patient products is desired)
- Experience in a Quality Assurance related role
- Experience in providing scientifically sound, risk based and pragmatic quality advice to manufacturing and quality control functions
- Experience writing and reviewing GxP documents (including SOP’s, ) to ensure good documentation, data integrity, GxP, quality and regulatory requirements are met.
- Working knowledge of GMP relating to sterile production, cleanrooms, aseptic technique and hygienic requirements for sterile products
- Exemplary attention to detail and record keeping demonstrating good documentation practices
- Good interpersonal and English language communication skills (written and verbal)
- Capable of managing a wide range of tasks, managing own time effectively
- Ability to work with integrity, to high ethical standards with an open-minded pragmatic approach
DESIRED SKILLS AND EXPERIENCE
- A working knowledge of regulatory requirements or processes that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s
- Knowledge of Tissues and Cells Directive and HTA requirements
- Experience of electronic Quality Management Systems
- Basic understanding of immunology
- Ability to assess risks and recommend pragmatic actions to control them
- High attention to detail
- Excellent interpersonal and communication skills (written and verbal)
- Capable of managing a wide range of tasks with minimal direction and prioritising tasks accordingly
- Highly self-motivated
- Pleasant manner, open minded, honest
- work with integrity and act as an ambassador for Quell and the wider business.
- Holidays: 25 days per year.
- Life Assurance: 4 x base salary.
- Group Personal Pension: Auto enrolled at 4% employer contribution, 4% employee contribution.
- Private Medical Insurance for your whole family.
- Annual Bonus.
- Fantastic collaborative environment at Translation & Innovation Hub
- £61 Million Investment including brand new lab equipment, innovative methods, and exposure to cutting edge technology.
- Flexible working.
- Fast paced and progressive company looking for future leaders and innovators.