Senior Quality Assurance Specialist - QA Compliance

Role Summary The post holder will work in the Product Delivery Quality Assurance team, supporting the delivery of autologous CAR T-cell products in compliance with Good Manufacturing Practice (GMP). The role will be based in Stevenage. Key Responsibilities Maintaining the requirements of GMP in a multi-product facility delivering cell and gene therapies Control of record forms for production and QC, ensuring traceability and maintaining an audit trail Preparation, checking, and issuing of in-process and Drug Product labels, ensuring compliance with templates and batch-specific data Review of Batch Manufacturing Records and QC records, and escalation of quality issues Authoring, approval, and review of GxP documentation Supplier management, including assessments, audits, and qualification/disqualification Materials review and release for production and QC Management of the Pharmaceutical Quality System (PQS), including change controls and deviations Continuous improvement initiatives Process and equipment qualification and validation Analytical and QC assay validation First point of escalation for issues and communication with QPs Collation and trending of Quality KPIs Supporting Product Quality Review Conducting internal audits as lead auditor Supporting regulatory inspections Line management of Junior Quality Assurance colleagues Demonstrated skills and competencies E – Essential, P – Preferred Experience 2-5 years’ experience in quality assurance within pharmaceutical or similar industries Experience with MHRA and HTA inspections Qualifications BSc in pharmaceutical sciences, immunology, or equivalent (E) MSc in pharmaceutical sciences, immunology, or equivalent (P) Skills/Specialist knowledge GMP & GCP principles Manufacturing and testing procedures for advanced therapies Understanding of CAR T-cell technology Strong communication and motivational skills Ability to build cross-departmental relationships Teamwork and accountability Ability to work independently to high standards #J-18808-Ljbffr