Quality Leadership Role
The successful candidate will lead and develop an experienced Quality team, ensuring all products are manufactured in line with GMP and MHRA Regulations. As a key member of the Senior Leadership Team (SLT), you will drive business forward, develop current processes, and deliver continuous improvement throughout the Quality function.
Key Responsibilities:
* Verify and ensure that all processes and procedures, including effective data management systems, policies, processes, and programmes, provide assurances of ongoing statutory, regulatory, and MA compliance.
* Elevate any quality issues detected during batch review as a key member of the SLT.
* Host MHRA inspections, write responses, and liaise with the MHRA Inspectorate.
* Provide effective oversight of all remediation projects from a quality perspective.
* Responsible for reviewing and closing Deviations, OOS, CAPA, and Change control.
Requirements
To succeed in this role, you should have:
* A BSc or above in a suitable Scientific/Pharmaceutical Discipline.
* Significant experience in a Quality Management/Leadership position within the Pharmaceutical Industry.
* In-depth working knowledge of EU GMP guidelines and other regulatory requirements.
* The ability to act as a Qualified Person is desirable but not essential.