Job type
PermanentLocation
LondonWorking Pattern
Flexible Working,Full-timeSpecialism
Life Sciences ManufacturingIndustry
PharmaceuticalsPay
90,000
Senior GCP QA Manager
Your new company
This Biotech was founded in 2019 and is currently disrupting the world of cell tumours. After a successful series B raise in Q1 2024, they are looking to further develop their clinical pipeline. Through organic growth, they are looking to appoint a GCP QA expert within their Quality team to lead clinical QA activities.
Your new role
As Senior GCP QA Manager, responsibilities include serving as the Global Quality Lead and developing Clinical QA Oversight strategies and conducting quality risk assessments. You will also ensure GCP compliance with the Biotech’s QMS and regulatory requirements, identifying and implementing corrective actions as needed. Conducting regulatory inspections and audits of clinical study sites, vendors, internal systems, and procedures, and manage quality issues will also be a major part of this role.
What you'll need to succeed
• B.Sc. in a Life Sciences discipline
• Minimum 5 years of experience with GCP (and other GxP) QA experience
• Audit & regulatory inspection experience (ideally MHRA and FDA)
• QMS and compliance experience
• Experience in a biotech, CRO, consultancy or pharmaceutical company
What you'll get in return
Flexible working options are available.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
This Biotech was founded in 2019 and is currently disrupting the world of cell tumours. After a successful series B raise in Q1 2024, they are looking to further develop their clinical pipeline. Through organic growth, they are looking to appoint a GCP QA expert within their Quality team to lead clinical QA activities.
Your new role
As Senior GCP QA Manager, responsibilities include serving as the Global Quality Lead and developing Clinical QA Oversight strategies and conducting quality risk assessments. You will also ensure GCP compliance with the Biotech’s QMS and regulatory requirements, identifying and implementing corrective actions as needed. Conducting regulatory inspections and audits of clinical study sites, vendors, internal systems, and procedures, and manage quality issues will also be a major part of this role.
What you'll need to succeed
• B.Sc. in a Life Sciences discipline
• Minimum 5 years of experience with GCP (and other GxP) QA experience
• Audit & regulatory inspection experience (ideally MHRA and FDA)
• QMS and compliance experience
• Experience in a biotech, CRO, consultancy or pharmaceutical company
What you'll get in return
Flexible working options are available.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.