QA Manager
CK Group are recruiting for a QA Manager on behalf of a growing Cell Therapy CDMO, to lead the establishment of a quality framework for use in manufacture of ATMPs. This role will be based at their site in Cambridge, on a permanent basis.
The Role:
This is a key role which includes responsibility for developing the company's culture of regulatory compliance, continuous quality improvement and quality awareness in a risk-based Pharmaceutical Quality System (PQS), leading a small team of quality staff, and liaising with staff across the various departments within the company.
Responsibilities :
1. Deputise for Head of QA.
2. Ensure the PQS is in a state of compliance, monitoring the state of control and process performance.
3. Support QA team and all departments on appropriately investigating and identifying correct CAPAS for any quality record.
4. Review metrics and trends, lead site management review meetings and produce/review quarterly and annual quality reports.
5. Ensure change control process allows for compliance through smooth operation of the change control process.
6. QA review of batch records, ensuring prompt closure of quality records that are impact the batch.
Your Background:
7. MSc or equivalent experience in a life sciences subject.
8. Significant experience working as a quality manager within a GMP Quality department in the manufacture of cell and /or gene therapy products.
9. Experience of working with regulatory bodies and preparing sites for regulatory inspection.
10. Experience of managing, developing and supporting a team.
11. Strong organisational skills with the ability to prioritise and work under pressure.
12. Ability to engage and influence at senior management level.