A cutting-edge biotech who are leading the way in the commercialisation of cell & gene therapies are recruiting for a Quality Assurance Lead with expertise in FDA regulations. With the purpose of the role to manage the revision of their PQS to ensure they comply with the FDA regulations ahead of the manufacture of ATMP’s for use in US based clinical trials.
The company are a centre of excellence that is at the forefront of creating a viable and sustainable cell and gene therapy industry. Their headquarters are in central London where they have built a leading multidisciplinary team that has the ability to take a therapy from concept through the development cycle to the market. With sector leading expertise to overcome the challenges face commercialising these therapies providing the scientific, clinical and commercial expertise needed to overcome the challenges. Once therapies have crossed the translational gap they have the capabilities to successfully complete non clinical studies to then take therapies through clinical trials with therapies now entering phase III trials.
The role of the Quality Assurance Lead is to manage the revision of the PQS so that it is in compliance with US cGMP / FDA regulations. This is a senior level and highly visible role where you will develop the strategy for US cGMP compliance using your expertise in this area to then implement the strategy. Identifying all the relevant areas where the regulations are applicable across the manufacturing centre and work in collaboration with the relevant stakeholders to ensure compliance is achieved.
You will assume a day to day responsibility for the management of the project providing regular updates, troubleshooting suing your knowledge and deliver the project. As the QA Lead you will be the subject matter expert for internal colleagues as well as collaborators who operate in this multi occupancy facility. Providing expert advice on US FDA requirements to relevant parties and promote awareness of regulations suing your own expertise.
Desired Skills and Experience:
For this opportunity you will need to have a in depth understanding of US cGMP / FDA regulations within an aseptic manufacturing, biologic, biopharmaceutical, or ATMP manufacturing environment. In addition to this you will need experience in leading / participating in US FDA audits as well as delivering PQS improvements.
Please note: THis is a Fixed Term Contract for 21 months
Quality Assurance Lead - FDA- Fixed Term Contract
|Job Title:||Quality Assurance Lead - FDA- Fixed Term Contract|
|Salary:||£50000 - £65000 per annum, Benefits: bonus, pension. life insurance, health insurance and 28 days holiday|
|Contact Name:||James Hume|
|Job Published:||March 11, 2020 16:38|
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