Temporary project: initially a 6-month contract
Location: Henley-on-Thames, London
Full-time basis: 3 - 5 days / week on-site
Our client requires support to their (Pre) commercial cell therapy EU operations on an initial 6 Month Contract. The candidate is to be of Senior Management Level, a QA Generalist and who can act on their own initiative and can drive projects forward. The successful candidate will report into the QA Senior Director. There will be no direct support for this role. The role will involve cross functional collaboration with other departments such as Supply Chain, Medical Affairs, PV and the US based Quality Team. Our client would like to have the position filled within the next 2 – 3 weeks.
The Scope of work will be 4 main areas:
- Development and Quality oversite of Cell Therapy Supply Chain
- Qualification of Clinical Sites. (Site visits may be required)
- Improving existing Quality Management System to ensure commercial readiness.
- Supporting the business as they set up pharmaceutical establishments in France and Germany including developing QMS, inspection readiness activities and hosting pre-approval inspections as required.
Quality Assurance Support
- Have experience in Good Distribution Practices
- Have experience dealing with external supply chain parties
- Have experience in managing clinical sites
- Have experience with cell therapy distribution and / or manufacturing
- Be familiar with hospital environments
- Be able to Project lead and provide project support
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.