Job Reference: J5633361
Updated On: 10/06/2020
Status: Open to Applications
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Role OverviewWe are currently looking for a QA Team Leader to join a leading Gene Therapy company based in London. As the QA Team Leader, you will be responsible for oversight of the site wide Quality systems, including management of a small team.
Key Duties and ResponsibilitiesYour duties as the QA Team Leader will be varied. However, the key duties and responsibilities are as follows:
1. You will implement and manage the Quality Management System, assuring Compliance to MHRA and FDA regulations; manage and oversee the GMP document management and document control process through full lifecycle.
2. As the QA Team Leader, you will manage the Quality Systems team and have a full oversight of the hiring and on-boarding process, through to coaching and mentoring, setting team objectives, managing the team performance and the development of staff.
3. You will ensure Audit Readiness and coordinate preparations for Regulatory Inspections; oversee and review Quality Risk Management, Deviations and their investigations; and ensure implementation of appropriate CAPAs and Change Controls, whilst ensuring they are monitored through to closure.
4. As the QA Team Leader, you will ensure the Quality Systems team works to Good Manufacturing Practice, Good Documentation Practice and Data Integrity Compliance.
Role RequirementsTo be successful in your application to this exciting opportunity as the QA Team Leader we are looking to identify the following on your profile and past history:
1. Relevant Life Sciences degree.
2. Proven industry experience in leading a QA team.
3. A working knowledge and practical experience within a Sterile GMP manufacturing environment is essential.
Key Words: QA | Quality Assurance | ATMP | Advanced Therapy Medicinal Product | Cell Therapy | Gene Therapy | Cell and Gene Therapy | QMS | Quality Management System | GMP | cGMP | Good Manufacturing Practice | GDocP | Good Documentation Practice | Data Integrity | MHRA | FDA | Compliance | Regulatory Inspections | Audit | QRM | Quality Risk Management | Deviation | CAPA | Change Control | Team Management | Training Staff
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