Head of Quality Assurance - Biologics GMP
|Job Title:||Head of Quality Assurance - Biologics GMP|
|Salary:||Up to £91,000 salary (pro rata for 6 months)|
|Contact Name:||Steve Twinley|
|Job Published:||October 01, 2020 17:39|
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.
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.
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