Job type
PermanentLocation
LondonWorking Pattern
Full-timeSpecialism
Quality Assurance And ValidationIndustry
PharmaceuticalsPay
75,000
QA Manager
Your new company
Listed on the LSE and NASDAQ, this global speciality Pharma is looking to further expand their operations across Europe. With the addiction and mental health crisis at the forefront of the agenda, they have a strong pipeline of products that hopes to cure serious mental illness by developing a treatment option for adults with various illnesses such as schizophrenia.
Your new role
- Manage, maintain and lead the company’s GCP QA audit program to support aspects of Phase I-IV global clinical trials.
- Conduct internal audits to assess the usability of the company’s GCP QMS and compliance system.
- Lead quality qualification audits for CROs, investigator sites, laboratory and clinical vendors to assess effectiveness of their QMS and compliance to approved clinical study protocols and contracts.
- Reporting of key metrics (KPIs), quality metrics, periodic quality reports and audits as needed.
- Support the cross functional site Quality Management Review (QMR) meetings.
What you'll need to succeed
- Bachelor of Science or Bachelor of Arts degree in a life science. Post graduate degree is preferred.
- Proven track record of GCP QA auditing experience in a regulated industry such as MHRA, FDA, pharmaceutical or biotech.
- Considerable knowledge of GCP, clinical trial regulations and quality assurance auditing techniques.
- MHRA and FDA Regulatory inspection readiness experience.
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 on your career.
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