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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
