Senior Specialist II, QA Supplier Management

Autolus Limited; Stevenage; On-site; GBP 45,000 - 65,000; Full time

Job summary

A biopharmaceutical company based in Stevenage is seeking a Quality Assurance professional to support the delivery of autologous CAR T-cell products. The role involves ensuring compliance with GMP, managing quality systems, and leading audits. Candidates must have over 5 years of experience in QA, preferably in an industrial setting, and a degree in pharmaceutical sciences or a related field. This position offers a collaborative work environment with opportunities to mentor junior staff.

Qualifications

• Minimum 5 years’ relevant QA experience, preferably in an industrial setting.
• At least 2 years’ experience in QA and management of sterile/ATMP products.
• Experience with MHRA or other health authorities and HTA inspections.
• Meet requirements to work in a cleanroom environment.

Responsibilities

• Maintain GMP requirements in a multi-product facility.
• Control record forms for production and QC.
• Author, approve, and review GxP documentation.
• Ensure cGMP compliance in batch release activities.
• Lead internal audits and support regulatory inspections.

Skills

GMP & GCP principles

Manufacturing and testing procedures for advanced therapies

CAR T-cell technology basics

Leading audits and hosting inspections

Project design and management

Strong communication and motivational skills

Ability to build cross-departmental relationships

Teamwork, accountability, and independent working skills

Leadership and influence capabilities

Education

BSc in pharmaceutical sciences

MSc in pharmaceutical sciences

Training to become an EU Qualified Person

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 GMP site in Stevenage (UK). You will work with a team of quality professionals to provide high-quality service to external service users.

Primary Responsibilities

1. Maintain GMP requirements in a multi-product facility delivering cell and gene therapies for clinical trial and commercial purposes.
2. Control record forms for production and QC, ensuring traceability and maintaining an audit trail.
3. Review Batch Manufacturing Records and QC records, escalating quality issues.
4. Author, approve, and review GxP documentation.
5. Ensure cGMP compliance in batch release activities through interaction with various functions.
6. Act as QA representative and manage the Pharmaceutical Quality System (PQS), including change controls, deviations, and other quality issues.
7. Review and qualify (or disqualify) third-party suppliers, including audits and risk assessments.
8. Review and release materials for production and QC, ensuring only approved suppliers are used.
9. Identify and drive improvements for the PQS.
10. Author, review, and approve qualification and validation protocols and reports.
11. Serve as the first escalation point for issues and communicate with QPs.
12. Monitor and trend Quality KPIs.
13. Contribute to the authoring of Product Quality Review reports and conduct periodic reviews.
14. Lead internal audits and support regulatory inspections.
15. Manage quality projects and serve as QA SME in complex projects.
16. Conduct risk management activities and train staff.
17. Lead inspection readiness activities and support QA management as needed.
18. Mentor and supervise junior QA colleagues and QA Associates.
19. Participate in updates within the Quality Directorate and adhere to health and safety policies.
20. Support manufacturing authorization management, including GMP license variations and regulatory dossier amendments.

Demonstrated Skills and Competencies

Experience

• Minimum 5 years’ relevant QA experience, preferably in an industrial setting, with responsibility for GxP standards.
• At least 2 years’ experience in QA and management of sterile/ATMP products.
• Experience with MHRA or other health authorities and HTA inspections.
• Meet requirements to work in a cleanroom environment.

Qualifications

• BSc in pharmaceutical sciences, immunology, biology, chemistry, or equivalent (E).
• MSc in the same fields (P).
• Training to become an EU Qualified Person (P).

Skills/Specialist Knowledge

• GMP & GCP principles
• Manufacturing and testing procedures for advanced therapies
• CAR T-cell technology basics
• Leading audits and hosting inspections
• Project design and management
• Strong communication and motivational skills
• Ability to build cross-departmental relationships
• Teamwork, accountability, and independent working skills
• Leadership and influence capabilities (P)