Senior Quality Assurance Specialist

Skills Alliance Enterprise; Stevenage; On-site; GBP 42,000 - 64,000; Full time

Job summary

Skills Alliance Enterprise is seeking a Quality Assurance professional to support the Product Delivery team in autologous CAR-T manufacturing under GMP. You will ensure compliant, timely batch release and act as QA liaison across Manufacturing, QC and QP stakeholders.

Ideal candidates have 2–5 years in sterile pharmaceutical QA, a BSc in life sciences or MSc in pharma/immunology, and strong GMP knowledge with proven documentation and cross-functional communication skills.

Qualifications

• Experience in sterile pharma manufacturing quality assurance.
• 2–5 years in QA for sterile manufacturing.
• GMP documentation experience.

Responsibilities

• Provide day-to-day QA support to GMP manufacturing operations for autologous CAR T-cell products.
• Review Batch Manufacturing Records and Quality Control records to support batch certification and product release.
• Manage deviations, investigations, OOS/OOT results, environmental monitoring excursions, CAPAs and change controls.
• Assess quality issues during manufacturing, ensuring appropriate investigation, documentation, escalation and resolution.
• Act as a QA point of contact for Manufacturing, QC and other cross-functional stakeholders, escalating significant quality issues to Quality leadership and Qualified Persons (QPs).
• 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.

Skills

GMP knowledge

QA in GMP

Deviation management

Batch records review

Cross-functional comms

CAR-T familiarity

Education

BSc, Life Sciences

MSc, Pharma/Immunology

Job description

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.

Role Summary:

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.

Key Responsibilities:

• 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

Demonstrated Skills and Competencies

Experience:

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

Qualifications:

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

Skills/Specialist Knowledge:

• 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