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.
THE 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
THE ROLE
The Senior Manager / Associate Director - Site QA is responsible for managing and is accountable for all site related QA operations as part of the Site Leadership Team (SLT), providing comprehensive high level specialist expertise to both the QA team and key stakeholders in relation to this Quell manufacturing site.
The role has responsibility for building and managing a small team of QA professionals and creating a strong quality culture on the site. The individual will deputise for the Senior Director, QA as required and assist in developing and implementing quality strategy for site and for other areas with in Quell.
Experience
- Min 12 years’ experience in GMP manufacturing environment mostly in QA/Quality related roles (in particular small scale e.g. ATMP’s, clinical trials or individualized patient products is desired)
- Significant experience of providing QA support to the manufacture of ATMP’s
- Significant experience of effectively building and developing small teams of QA professionals
- Demonstrated experience of building a quality focused culture of continuous improvement
MAIN RESPONSIBILITIES
- Responsible for managing QA operations at a site level as defined in Quality Agreements and as governed by GMP
- Represents QA on the SLT
- Responsible for leading site and QA team adherence with the local or corporate QMS
- Assist in the development of the Quell PQS including establishing an eQMS where relevant
- Defines and develops new quality processes, policies and data management including setting up quality standards and metrics ensuring they are met
- Responsible for the set up of relevant Quality metrics and KPI’s, monitoring for trends and assessing the effectiveness of the quality management systems. This includes producing and presenting these on a regular basis including to the SLT and to the Quell Executive Team at Quality review meetings
- Use the above quality metrics and trends to reduce risks to patient safety (including risk to batch failures), improve compliance, data integrity or improve business processes
- Identifies and communicates significant quality related matters or risks that could have major impact on product quality, product release or regulatory compliance that affect the site
- Oversees and performs complex QA activities involving evaluating and reviewing processes to ensure manufacturing, testing and clinical trials activities comply with GMP, GCP, HTA and other regulatory requirements relating to manufacture and clinical trials for cellular therapies and AT(I)MPs including
- Responsible for ensuring starting materials are procured, tested, and imported as required according to UK HTA requirements
- Manage and monitor the following elements of the PQS relating to manufacture of cellular therapies including;
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o document control system |
o quality risk management |
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o training system |
o qualification & validation |
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o change controls |
o leading Internal audits |
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o corrective and preventative actions (CAPA) |
o vendor qualification |
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o deviation & OOS reporting |
o batch record review prior to QP release |
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o manage Product Specification Files for ATIMP’s |
o complaint and recall handling |
- Develop, review and approve Quality and GxP related documentation
- Leads, conducts and coaches other in risk assessment and investigations as required
- Approves the quality and suitability of equipment, materials and services for the site
- Leads external audits as necessary
- Defines local Quality Strategy and assist with the development of overall Qualify strategy for Quell
- Organize and deliver QA related training and deliver basic GMP training as required
- Act as subject matter expert on all Quality related processes as required
- Lead or represent QA in related projects as required identifying quality related metrics, issues and mitigation actions
- Builds a strong quality culture and one of continuous improvement within team and ensuring this is promoted by other members of the Site Leadership Team
- Responsible for inspection readiness preparation, and directly supports regulatory agency inspection. Responsible for coordination of response to any findings
- Responsible for recruiting, leading, motivating and developing a group of QA professionals
- Supporting other quality related activities across sites as required
- Deputises for Senior Director, QA as required
TECHNICAL REQUIREMENTS
- Experience in providing scientifically sound, risk based and pragmatic quality advice to manufacturing and quality control functions
- Extensive experience writing and reviewing GxP documents (including SOP’s, qualification/validation reports and batch records prior to QP review) to ensure good documentation, data integrity, essential GxP, quality and regulatory requirements are met
- Expert knowledge of GMP relating to sterile production, cleanrooms, aseptic technique and hygienic requirements for sterile products
- Extensive knowledge of regulatory requirements or processes that specifically apply for the manufacture and/or testing of cell therapy products and/or ATMP’s
- Experience of generating metrics and using these to demonstrate PQS effectiveness, improving compliance and reducing risks
- Proficient understanding of HTA requirements relating to Tissues and Cells
EDUCATION
- University degree in a biological science, chemistry or equivalent
- IRCA Associate auditor certified desired
