Quality Assurance Manager - Cell and Gene Therapy 60-100%
About the Company - This organisation specialises in Cell Therapy, blood products, genetic sequencing/testing and processing.
About the Role - Provide expert advice, to all levels of the organisation including members of the leadership forum, on the complex, multi-stranded regulations relating to our laboratory services. To lead and motivate the Quality Managers to achieve individual and team performance objectives and empower people by delegating responsibility appropriately. This includes oversight over the QMS workloads for the team and ensuring resource is allocated to meet the demands of the service delivery function and to avoid any backlogs or delays in the processes (for e.g. quality team approvals for the QMS, quality reviews for product release processes, quality reviews for documents and quality incidents). Proactively plan for changes in this environment. Proactively monitor regulatory changes in the environment and ensure the organisations on-going compliance with legislation and accreditation requirements, and voluntary best practice codes of conduct.
Responsibilities -
- Provide expert advice on complex regulations
- Lead and motivate Quality Managers
- Ensure resource allocation for service delivery
- Proactively plan for changes
- Monitor regulatory changes
- Oversight over the QMS workloads for the team and ensuring resource is allocated to meet the demands of the service delivery function and to avoid any backlogs or delays in the processes
- Quality reviews for product release processes, quality reviews
Required Skills - Knowledge of the below regulations is compulsory:
- Human Tissue Authority (HTA)
- ISO 15189
- FACT
- JACIE
If you’re interested in the role above, please reach out to lexi.quintyne@biotalent.com
