Senior QA Specialist - Biologics GMP

Are you a QA professional with a background in Biologics / Biopharmaceutical manufacturing? Can you start at short notice? We are recruiting a Senior QA Specialist to join a pioneering cell & gene therapy company in Stevenage (though you will be home-based to begin with). If you have strong expertise in either Deviation and Change Management, or Supplier Management (from a Quality perspective) then this could be a fantastic career opportunity.

This role is offered on a fixed-term contract basis (to cover maternity leave) for 12 months. There is a chance of extension beyond this but it cannot be guaranteed. The role is at Senior QA Specialist level and is paying a very generous equivalent salary depending on experience (to discuss on application).

The Company: You will join a genuinely exciting and unique organisation in the manufacture of Advanced Therapy Medicinal Products and Gene Therapies to treat cancer. The company has an excellent reputation for its forward-thinking science, its busy and friendly environment and the collaborative nature of how each team works together.

The Role : You will have leadership responsibilities within a small QA team, providing guidance and training to less experienced members of the team. You will take charge of a range of projects. One of the current roles has a focus on Deviation and Change Management; and the other role is based around Supplier Management and associated technical agreements, SOPs and inspections. As a Senior QA Specialist, you will have significant input into the ongoing development of the company’s QMS for GMP in a multi-product sterile production facility that delivers programmed T-cell therapies for clinical trials.

Requirements: We are looking for a Quality professional with a background in sterile GMP production, with a few years’ experience gained in a Biologics, Biopharmaceutical or Cell & Gene Therapy manufacturing environment. You will ideally have a strong educational background, though the key things are to demonstrate excellent communication skills, a pragmatic and collaborative approach to quality, and experience in hosting or being involved in inspections (MHRA, HTA etc).

Full details will be provided on application. This is a fixed-term role in Stevenage, Hertfordshire. However, due to Covid19, your role will be primarily home-based for the time being.