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: 

• Deputise for Head of QA.
• Ensure the PQS is in a state of compliance, monitoring the state of control and process performance.
• Support QA team and all departments on appropriately investigating and identifying correct CAPAS for any quality record.
• Review metrics and trends, lead site management review meetings and produce/review quarterly and annual quality reports.
• Ensure change control process allows for compliance through smooth operation of the change control process.
• QA review of batch records, ensuring prompt closure of quality records that are impact the batch.

 

Your Background:

• MSc or equivalent experience in a life sciences subject.
• Significant experience working as a quality manager within a GMP Quality department in the manufacture of cell and /or gene therapy products.
• Experience of working with regulatory bodies and preparing sites for regulatory inspection.
• Experience of managing, developing and supporting a team.
• Strong organisational skills with the ability to prioritise and work under pressure.
• Ability to engage and influence at senior management level.

 

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference (phone number removed) in all correspondence