Senior Specialist II, QASM

**Work with us** Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and Autoimmune disease to deliver life-changing treatments to patients.Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus.**Job Description:****About Autolus**Autolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this Autolus is proud to offer a competitive salary, performance related bonus as well as private medical insurance, life assurance, pension and access to an employee share scheme. Autolus promotes flexible working.**Our Promise**Autolus is developing complex, breakthrough therapies for a globally diverse market and equally recognises that diversity amongst our people is critical to our mission. As we draw on our differences, what we’ve experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees.**Role Summary**Based in Stevenage, the post holder will work within the Quality Assurance team, supporting the delivery of autologous CAR T-cell products for commercial purposes and clinical trials operating in sites across the UK, EU and US from a central Good Manufacturing (GMP) site in Stevenage (UK). You will be expected to work with a team of quality professionals to provide a high-quality service to external service users.Please note that this is a hybrid role.**Primary Responsibilities*** Maintaining the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies for clinical trial and commercial purposes.* Control of record forms for use in production and QC, applying batch or test article identity traceability features and maintaining an audit trail of issue, use and reconciliation and archiving.* Review of Batch Manufacturing Records and Quality Control records and escalation of quality issues* Authoring, approval and review of GxP documentation.* Interact with various functions to ensure cGMP compliance in batch release related activities.* Competently act as QA representative and manage the Pharmaceutical Quality System (PQS) including change controls, deviations, complaints, QC invalid, out-of-trend and out-of-specification results and other environmental excursions.* Review and qualification (or disqualification) of 3rd Parties, including audits, desk-based reviews and conducting risk assessments.* Review and release for use in Production and QC, ensuring that only approved suppliers and materials are available.* Pro-actively identify and drive improvement initiatives for the Pharmaceutical Quality System (PQS).* Competently author, review and approve qualification and validation protocols and reports for process and equipment, analytical assays.* First point of escalation issues and communication to QPs* Collation and trending of Quality KPIs.* Contribute to the authoring of Product Quality Review reports.* Conduct the review of Periodic Quality Review reports.* Conduct internal audits as lead auditor in accordance with a defined schedule.* Support regulatory inspections – backroom support and/or SME support.* Act as Project Management Lead in Quality projects and act as QA representative/SME in larger and more complex projects.* Conduct and/or facilitate risk management activities.* Train other members of staff including non-Quality staff.* Lead inspection readiness activities.* Deputise for QA Manager and act as supervisor, mentor or coach of junior Quality Assurance colleagues.* Act as line manager for QA Associates.* Provide unsupervised support to other QA teams.* Present within the Quality Directorate, updates with respect to changes, unplanned events and projects.* Work in adherence to local Health and Safety policies and SOPs.* Any other duties as required following consultation with the post holder.Secondary/Other Responsibilities* Supporting in manufacturing authorisation management, including GMP licence variations, Clinical Trial Authorisation management, including amendments to regulatory dossiers (e.g.: MAA, IMPD, IND, BLA etc.).Demonstrated skills and competencies**E – Essential P – Preferred****Experience*** At least 5 years’ relevant (ideally industrial) experience in a Quality Assurance role in a PQS, with direct responsibility for maintaining the standards of the relevant GxP (E).* At least 2 years’ working in the quality assurance and management of Sterile/ATMP (P).* Experience with MHRA or other internationally recognised competent health authority (E) and HTA (P) inspections, either as host or involved contract giver to a manufacturing site.* Meet requirements to work in cleanroom environment (P).**Qualifications*** BSc in pharmaceutical sciences, immunology, biology, chemistry or equivalent experience (E).* MSc in pharmaceutical sciences, immunology, biology, chemistry or equivalent experience (P).* Training to become an EU Qualified Person (P).**Skills/Specialist knowledge*** GMP & GCP principles* The manufacturing and testing procedures for advanced therapies* The basis of CAR T-cell technology (P)* Leading audits, and hosting inspections and audits (P)* Project design and project management (P)* Good communication skills and ability to motivate colleagues* Ability to build strong collaborative cross-departmental relationships* Skills to work within a team, understanding his/her responsibilities and delegating to others and remain accountable for his/her work* The ability to work independently to a high standard with minimal direction from a manager* The ability to lead and influence other staff members (P)Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard.Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.### Get In TouchIntroduce yourself to our recruiters and we\’ll get in touch if there\’s a role that seems like a good match. #J-18808-Ljbffr