Job Description

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-ofspecification

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)