Head of Quality Assurance - Biologics GMP

Head of Quality Assurance - Biologics GMP

Job Title: Head of Quality Assurance - Biologics GMP
Contract Type: Contract
Location: Stevenage
Salary: Up to £91,000 salary (pro rata for 6 months)
Start Date: 2020-09-30
Reference: V-46397
Contact Name: Steve Twinley
Contact Email:
Job Published: October 01, 2020 17:39

Job Description

A brand-new vacancy has recently in Stevenage, Herts for a Head of QA to join a leading cell & gene therapy organisation on an interim basis for 6 months. If you have experience of GMP quality systems in a Phase III / commercial biologics, vaccine or ATMP manufacturing environment, this will be an excellent career opportunity.
You will be paid up to £91,000 salary (pro rata for 6 months) and the company is well-known for its collaborative, forward-thinking environment and internal communication. Full details will be provided on application.
The Role
This role reports to the Director of Quality and is a fixed-term position in which you can make an immediate impact. You will participate in the translation of strategic direction into a framework of Quality processes and systems to define, guide and govern the application of GMP compliance maintenance for the company’s manufacturing facility in Stevenage.
You will lead a multi-disciplinary QA team to assure GMP compliance, and will be responsible for actively promoting the awareness of quality requirements throughout the company. You will review the performance of the QMS (including for external suppliers) and will manage an internal self-inspection programme, including the identification and implementation of corrective actions and a system to track their completion.
We are looking for a highly motivated, practical QA professional with a pragmatic approach to Quality, and who enjoys collaborating with internal and external parties. You will need strong QA leadership experience from a Phase III / commercial biologics environment, whether this is in vaccine manufacture, cell & gene therapy production or similar setting, interfacing with R&D. You will have overseen and developed GMP quality systems, with extensive knowledge of EU / MHRA and US / FDA regulatory requirements.