Job Reference: J5636081
Updated On: 12/04/2022
Status: Open to Applications
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Role OverviewI’m currently looking for a Quality Compliance Lead to join a leading Gene Therapy business based in the London area. As the Quality Compliance Lead you will be responsible for implementing and assuring a GCP/GLP Quality Management System, as well as the following:
Key Duties and ResponsibilitiesKEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Compliance Lead will be varied however the key duties and responsibilities are as follows:
1. Provide QA oversight and technical QA expertise, support and leadership across the Pre-Clinical and Clinical Operation across the business.
2. Lead and perform audits including audits of clinical investigator sites, managing the clinical and preclinical internal and external audit programme, as well as auditing of associated clinical documentation and businesses operations related to GCP, GCLP, GLP and GPvP.
3. Act as a technical resource to resolve GCP/GLP issues based on knowledge of regulations, guidelines and relevant SOP’s.
4. Responsible for analysis and reporting of clinical quality KPI’s, and data to identity potential trends and risks, reporting for the senior leadership team.
Role RequirementsROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Quality Compliance Lead we are looking to identify the following on your profile and past history:
1. Relevant degree within life sciences or equivalent practical experience
2. Proven industry experience within a GCP and GLP environment with experience of early and late phase clinical trials within the pharmaceutical industry.
3. A working knowledge and practical experience of hosting audits to GCP and GLP regulations.
Key Words: Quality Lead, Compliance, GCP, GLP, Pharmaceutical, Cell & Gene Therapy, Clinical Trial, Audit
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.
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