Senior Quality Assurance Specialist
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 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
Senior QA Specialist
The QA Specialist is responsible for carrying out a variety of QA activities and provides guidance and advice to key stakeholders in relation to the Quell manufacturing sites.
- Proposes measures and improvements to enhance the Quell PQS operations
- Responsible for monitoring a wide range of QA duties ensuring end to end product standards are adhered to whilst conducting tests to ensure compliance 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
- Day to day responsibilities include 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
- Leading internal audits
- Vendor qualification
- Batch record review prior to QP release
- Maintaining product specification files for ATIMP’s
- Supports QA risk assessment and investigations as required
- Draft, review and approve Quality and GxP related documentation
- Provides advice and guidance to the Quell manufacturing and QC teams on Quality related issues
- Produces and review KPI’s and quality metrics
- Identifies quality related matters or risks that could impact product quality, product release or regulatory compliance.
- Provide support and advice for other functions within the business e.g. R&D / clinical trial sample testing / process development teams as required
- Deliver QA related training as required
- Act as SME in specific quality related areas as required
- Lead or represent QA in related projects as required
- Promote quality culture and one of continuous improvement within team
- Min 4 years’ experience or equivalent experience working in a Quality Assurance role in a GMP environment
- Previous experience with supporting the manufacture of ATMP’s, or equivalent products e.g sterile products, small scale manufacturing
- 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
- Ability to work collaboratively within a team, supporting one another and held accountable for project deliverables.
- Personal drive and goal orientation.
- Detail-orientated and accurate.
- Professional and personable communication skills.
- Driven to solve problems pragmatically.
- Demonstrates strong organisational and prioritisation skills to manage a diverse workload.
- Excellent working attitude, reliability, and flexibility.
- Desire to work with integrity and act as an ambassador for Quell and the wider business.
- Flexibility to work across multiple sites in London (Guys and St Thomas’ (GSTT) and White City)