Job Description
Location of role UK- Oxford
Department Clinical QA
Key Responsibilities The Quality Assurance (QA) Manager will primarily provide quality oversight by collaborating with and supporting those departments/functions involved in chemistry, manufacturing and controls (CMC) and good manufacturing practice (GMP) operations pertaining to investigational (IMP) and licensed medicinal products and associated processes at Immunocore.
The QA Manager will work with the established GxP Quality Management System (QMS), with internal colleagues and third parties to ensure the compliance of CMC/GMP processes with the relevant regulatory framework and internal quality requirements.
Where applicable, this role will require the provision of quality oversight and support for departments/ functions/ processes involving research and human tissue management.
Where applicable, this role will influence/ impact wholesale distribution activities and therefore an understanding of the requirements of good distribution practice (GDP) as defined in Directive 2001/83/EC and various national legislation where Immunocore operates, is essential.
Key Responsibilities:
1. Provide quality oversight and support for:
2. CMC and GMP operations, ensuring compliance to the relevant regulatory framework and internal...