Senior Specialist II, QA Supplier Management

This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.

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.

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).