Senior GCP Compliance Manager

QA, Quality, GCP, compliance

Your new company
This US Biotech was founded in the late 1990’s and has rapidly expanded since. With strong growth plans, a powerful portfolio of drugs and increased pipeline, they are one of the world’s most exciting Biotech’s. They specialise in delivering therapies for rare diseases and specialise in the genetics market and are currently developing, manufacturing and focussing on the commercialisation for rare genetic disorder therapies.

Your new role
As GCP Compliance Senior Director, you will be the ‘voice of compliance.’ This is a brand new role due to an increase in the GCP Compliance work load, you will work alongside colleague’s in the US as an individual contributor and support clinical operations, medical affairs team and carry out risk based GCP compliance. You will also carry out investigator site audits as well as prepare and host regulatory (MHRA & FDA) inspections.

What you'll need to succeed
10 years of experience across clinical QA
GCP Compliance experience
Carried out regulatory audits such as MHRA and FDA

What you need to do now
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Job type:
Working Pattern
Quality Assurance and Validation
Apply Now

Talk to a consultant

Talk to Chandni Pankhania, the specialist consultant managing this position, located in London-City

4th Floor, 107 Cheapside

Telephone: 02034650133

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