ABOUT US
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
Provide support, oversight and act as main point of contact to Quell laboratories performing exploratory analysis of clinical trial patient samples to help establish best practice and ensure integrity of data. Provide support and act as main point of contact to Quell R&D laboratories to help establish best practice and ensure integrity of data. As required, support the Senior Clinical Quality Assurance Manager in QA related tasks to support to clinical trials being conducted by Quell Therapeutics Ltd.
Provide day-to-day management of the Quell Electronic Quality Management System and act as system administrator. Help establish and manage the Quality System as it relates to GCP including writing, reviewing, approving and/or maintaining Standard Operating Procedures and other clinical documentation.
MAIN RESPONSIBILITIES
Reporting to the Senior Clinical Quality Assurance Manager coordinate the implementation of the company quality management system relevant to GCP (including laboratory analysis of clinical samples) including external vendor oversight, training on quality procedures and monitor performance against agreed standards.
- Serves as main point of contact and support for Immunomonitoring and R&D labs. Provides support and back-up to Senior Clinical Quality Assurance Manager in quality assurance aspects of the Quell Clinical Trials.
- Evaluates and/or reviews documentation generated by internal or external parties (e.g. SOPs, Essential documents, Clinical Plans)
- Writes and/or reviews QMS documents (e.g. SOPs)
- Act as system administrator for eQMS and perform day-to-day management of documents within the system
- Generation and monitoring of quality metrics including those from the eQMS
- Assists with the selection and supports the qualification process for selected external vendors and provides oversight for outsourced contracted laboratory activities.
- Supports the Senior Clinical Quality Assurance Manager in the planning and conduct of audits, including internal, vendors, clinical sites, external laboratories, suppliers.
- Provides support to establish fit for purpose practices that ensure traceability and data integrity for internal laboratories in particular those analysing clinical patient samples
- Provide GCP/GCLP/GLP guidance as appropriate to clinical project teams, including risk identification/mitigation of potential of identified operational issues/deviations.
- Oversees, manages and provides input as needed for Change Controls, Deviations and CAPAs in relation to the Quell Immunomonitoring and R&D laboratories. Participates in project meetings (internal and external) as Clinical Quality representative, as required.
- Assists in inspection readiness preparation, and/or directly supports regulatory agency inspection. Assists in coordination of response to any findings.
- Deliver training to laboratory teams as required.
- Deliver eQMS training to users as required.
- Assist in the archiving of GxP documentation and act as a deputy Company Archivist
- Promote quality culture and one of continuous improvement within Quell
EXPERIENCE
Min 4+ years of experience in pharmaceutical/biotechnology industry in a GCP QA role, including experience of providing quality support or oversight to Clinical laboratories
- Experience of providing this Quality support for Cell or Gene Therapy programmes is highly desirable
- Experience of working with and managing eQMS
- Experience of providing quality support or oversight to Clinical laboratories
TECHNICAL REQUIREMENTS
- Experience of conducting internal audits
- Expert knowledge of pharmaceutical regulations, standards, and current industry regulatory practices related to GCP and GCLP with an understanding of the considerations for ATMP’s
- Experience of eQMS’s including set up and administration
- Skilled at maintenance and monitoring of a QMS preferably including experience in a small/ start-up organisation environment.
- Experience in archiving is desirable
EDUCATIONAL REQUIREMENTS
- Bachelor’s Degree in Life Sciences, Pharmacy, Regulatory
- Understanding of immunology is desirable
