Senior Quality Assurance Specialist

Our client 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 defense mechanisms, and eliminate these cells.

They have a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumours, and autoimmune diseases.

The post holder will provide Quality Assurance support within the Product Delivery team, helping ensure the compliant and timely delivery of autologous CAR T-cell products in accordance with GMP requirements.

• Provide day-to-day Quality Assurance support to GMP manufacturing operations for autologous CAR T-cell products
• Review Batch Manufacturing Records, Quality Control records and associated GMP documentation to support timely batch certification and product release
• Manage and coordinate quality events, including deviations, investigations, OOS/OOT results, environmental monitoring excursions, CAPAs and change controls
• Assess quality issues arising during manufacturing, ensuring appropriate investigation, documentation, escalation and resolution
• Act as a key QA point of contact for Manufacturing, QC and other cross-functional stakeholders, escalating significant quality issues to Quality leadership and Qualified Persons (QPs) as appropriate
• Support the maintenance of batch and patient-specific product traceability throughout the manufacturing and release process
• Author, review and approve GxP documentation in accordance with established procedures and regulatory requirements
• Support the effective operation and continuous improvement of the Pharmaceutical Quality System (PQS), ensuring quality activities are progressed and closed within appropriate timelines
• Support regulatory inspection readiness and other QA compliance activities as required

• 2-5 years’ experience in sterile manufacturing in equivalent roles, with responsibility for quality assurance in a pharmaceutical or equivalent quality management system

• BSc degree in life sciences (E) or significant relevant industry experience
• MSc in pharmaceutical sciences, immunology or equivalent experience (P)

• Strong working knowledge of GMP principles within a pharmaceutical, biotechnology or cell and gene therapy manufacturing environment
• Experience providing QA support to manufacturing/operations within a GMP facility
• Experience with deviation management and investigations, including OOS results, environmental monitoring excursions, CAPAs and change controls
• Experience reviewing GMP manufacturing documentation and batch records to support batch certification and product release
• Ability to identify, assess and appropriately elevate quality issues to Operations, Quality leadership and Qualified Persons (QPs)
• Understanding of quality requirements associated with patient-specific manufacturing and autologous CAR-T products
• Ability to manage multiple quality activities in a fast-paced manufacturing environment where timely batch disposition is important
• Strong cross-functional communication skills with the ability to work independently and collaborate effectively with Manufacturing, QC and QP functions