ABOUT US
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.
OUR COMPANY
Quell Therapeutics Ltd (“Quell”), the world leader in the development of engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, announced it has raised $156 million in an oversubscribed Series B financing. The financing round was co-led by Jeito Capital, Ridgeback Capital Investments, SV Health Investors and Fidelity Management & Research Company LLC with participation from founding investor Syncona. New investors include British Patient Capital through its Future Fund: Breakthrough program, Janus Henderson Investors, Monashee Investment Management, Point72 and funds managed by Tekla Capital Management LLC
Job Title: QA Associate / Senior
Location: London City
THE ROLE
Quell is looking for a QA Associate / Senior 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.
MAIN RESPONSIBILITIES
- 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 to 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 and review KPI’s and quality metrics
- Provide Quality support for other areas of the business e.g., R&D, process, and analytical development processes to ensure best laboratory and data integrity practices
- Lead or represent QA in related projects as required
- Act as SME in specific quality related areas as required
- Promote quality culture and one of continuous improvement within team
EXPERIENCE WE ARE LOOKING FOR
- Experience in GMP manufacturing environment (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 SOPs) 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
- 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.
- Good interpersonal and English language communication skills (written and verbal)
- 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 is required
- Knowledge of Tissues and Cells Directive and HTA requirements
- Experience of electronic Quality Management Systems
- Basic understanding of immunology
PERSONAL QUALITIES
- Excellent team working and networking skills with experience of interacting effectively across interfaces of discipline, culture, and expertise
- Desire to work with integrity and act as an ambassador for Quell and the wider business.
BENEFITS
- Holidays: 25 days per year
- Life Assurance: 4 x base salary
- Group Personal Pension: Auto enrolled at 6% employer contribution, 3% employee contribution
- Private Medical Insurance for your whole family
- Annual Bonus
PERKS
- Fantastic collaborative environment at Translation & Innovation Hub
- $156 Million in 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
