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Hyper Recruitment Solutions
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QA Manager

Hertfordshire, Permanent
£50,000 - £60,000 per annum
Job Reference: J5632562
Updated On: 26/11/2019
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Biotechnology, Cell & Gene Therapy

Skills: Quality Assurance - Permanent, Quality Assurance - GCP, Quality Assurance - Compliance, Quality Assurance - Auditing, Quality Assurance - Quality Manager, Quality Assurance - IMP, Quality Assurance - ATMPs

Job Information

Role Overview

We are currently looking for a QA Manager to join a leading ATMP company based in the Hertfordshire area. As the QA Manager, you will be responsible for ensuring the compliance of clinical trial operations to GCP regulations.

Key Duties and Responsibilities

Your duties as the QA Manager will be varied. However, the key duties and responsibilities are as follows:

1. You will oversee the Clinical Operations team and provide support and guidance to the team, as required, to ensure they are working in a compliant and timely manner.

2. As the QA Manager, you will qualify, approve and manage the GCP service providers; assist in the compilation of the GxP audit plan and conduct external audits of GCP service providers.

3. You will conduct internal audits of the Quality Management System and GCP processes on site, and assist in regulatory body inspections.

4. As the QA Manager, you will review clinical protocols, SOPs and patient information leaflets for compliance to GCP standards, investigate deviations and implement appropriate CAPAs and change controls. You will also deliver training on GCP standards and facilitate sponsor release of ATIMPs.

Role Requirements

To be successful in your application to this exciting opportunity as the QA Manager we are looking to identify the following on your profile and past history:

1. Relevant Life Sciences degree.

2. Proven QA experience working to GCP standards in the biopharma industry with IMPs.

3. A working knowledge and practical experience with GCP service provider audits.


Key Words: QA | Quality Assurance | Pharmaceutical | Biotechnology | Biopharma | ATMP | Advanced Therapy Medicinal Products | IMP | Investigative Medicinal Products | Cell & Gene Therapies | GCP | Good Clinical Practices | MHRA | FDA | Regulatory Inspections | Internal Audits | Self-Inspections | External Audits | Deviations | CAPAs | Change Controls | QMS

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
Rhys Evans
Your Recruitment ConsultantRhys Evansrhys.evans@hyperec.com
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.