Senior GMP QA Specialist (12-month FTC Maternity Cover) Senior GMP QA Specialist (12-month FTC [...]

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 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 ROLE

The Senior QA Specialist (12-month FTC maternity cover) is responsible for the GMP oversight of clinical phase, gene-modified cell therapy product manufacturing and testing. This includes the execution and reporting of GSTT GMP PQS systems, the design, improvement, execution and reporting of Quell PQS systems, and oversight of outsourced GMP activities. This is an office-based role at Quell’s London Bridge office.

MAIN RESPONSIBILITIES

• Day to day responsibilities for execution and reporting of outsourced GMP PQS systems controlling the manufacturing and testing of clinical phase, gene-modified cell therapy products, in accordance with GMP including:
• Batch review and QP certification process
• Product Specification File maintenance
• Deviations
• Change Controls
• CAPA
• Responsible for the execution, reporting and phase-appropriate design of Quell PQS systems facilitating continuous improvement and knowledge management of clinical phase, gene-modified cell therapy products manufacturing and testing, including:
• Quality Risk Management
• Quality metric reporting
• Self-inspections
• Vendor qualification and monitoring
• Training
• EU QP batch review and certification
• Perform risk-based assessments of deviations, changes and other events impacting manufacturing and testing activities, whether internal or external, to ensure outcomes comply with GMP, the PSF, any relevant manufacturer’s PQS, Quell’s PQS and any other appropriate regulatory standards.
• Perform or support vendor qualification, re-assessment, and oversight for all outsourced activities affecting GMP manufacturing and testing activities of Quell’s products, in line with Quell’s PQS.
• Generate, report and maintain clear, real-time PQS performance metrics driving right-first-time manufacturing and testing.
• Draft, review and approve GMP documentation in accordance with Quell’s PQS requirements, GMP and other applicable regulatory standards, appropriate to the clinical trial phase and data criticality.
• Provide support and advice for other functions within the business, for example, process and analytical research and development, internal and external manufacturing teams, patient supply operations and clinical operations.
• Design and deliver PQS related training as required.
• Maintain oversight of PQS processes and provide guidance to ensure starting materials are procured, tested, and imported as required according to UK HTA requirements.
• Lead, or act as quality SME, in cross-functional projects.
• Attend Product Team Meetings, as required.
• Promote quality culture and one of continuous improvement within team.
• Support knowledge management within Quell and between external manufacturing sites whilst maintaining IP.

EXPERIENCE, TECHNICAL & EDUCATIONAL REQUIREMENTS

Technical Requirements

• Previous experience pharmaceutical quality assurance supporting the development and GMP manufacture of ATMPs, (or equivalent products e.g aseptically compounded Special’s, biologics, innovative medicines) and an applied knowledge of the GMP requirements of aseptic manufacturing.
• Working knowledge of regulatory requirements (UK and EU GMP, ICH) for clinical stage sterile products, including ATMPs.
• High attention to detail, strong organisational and communication skills, and ability to manage confidential and trade secret information appropriately.
• Ideally, experience of Lean processes supporting late-stage clinical trial or commercial ATMP or biologics processes.
• Experience in providing scientifically sound, risk based and phase-appropriate quality guidance to cross functional teams.
• Proven record of implementing, monitoring, and continuously improving quality systems and ensuring data integrity and compliance.
• Excellent written communication style, able to produce clear, succinct high quality GMP documents.
• Experience implementing, or working within, an eQMS.
• Demonstrated application of risk management tools.

Educational Requirements

• University degree in a biological science, chemistry or equivalent.

BENEFITS

• Holidays: 25 days per year
• Group Personal Pension: Auto-enrolled at 6% employer contribution, 3% employee contribution
• Private Medical Insurance for your whole family
• £61 Million Investment including brand new lab equipment, innovative methods, and exposure to cutting edge technology
• Fast paced and progressive company looking for future leaders and innovators.