ATMP QA Manager required for a growing CDMO based near Cambridge who are specialist in providing GMP manufacturing services for ATMPs and related products. They support the development of complex, breakthrough therapies for for a global market.
The ATMP QA Manager will lead the establishment of a quality framework for effective use in manufacture of Advanced Therapy Medicinal Products (ATMPs), in a continuously growing and expanding CDMO. This role includes responsibility for developing a 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.
The ATMP QA Manager will be responsible for monitoring, controlling and overseeing risk, change control processes and non-conformance management within the company, ensuring that they meet the requirements of multiple clients and regulatory authorities. The job holder will also be responsible for ensuring that the PQS is always in a state of control, for identifying and monitoring trends, and reporting such trends within the site management review.
On offer for the successful candidate is a competitive salary and benefits package.
The suitable candidate will have the following experience / knowledge:
The ability to showcase prior management experience
Extensive QA experience
Strong GMP background
Experience in an ATMP company (preferred)