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Are you an experienced Quality Assurance Leader looking for a challenge with a really exciting CDMO focused on Pharmaceutical Manufacturing?
Job Title: Quality Assurance Manager
Location: Northwest, England
SRG is currently working exclusively with a highly successful, award winning, contract development and manufacturing organisation focused on providing expert intelligence and support to their partners, driven by their capabilities.
As a result of expansion, we are looking for a Quality Assurance Manager to join their quality team.
Typical responsibilities/accountabilities:
- Lead a team of pharmaceutical Quality Assurance professionals working to the highest quality and compliance standards.
- Work with Qualified Person to enable the efficient evaluation and release of IMP to clinical studies on our clients' behalf.
- Take the lead on regulatory inspections and client audits and take accountability (with the Site Leadership Team) for the approval and maintenance of the site MHRA MIA (IMP) licence. To lead Management Reviews of Quality performance.
- To provide support and leadership on a range of activities including but not limited to: non-conformance management, including CAPA, events, root cause analysis, continuous improvement, key supplier issues, complaint investigations etc.
- To ensure compliance with regulatory filings and regulatory agency reporting, and the implementation of compliance site initiatives and procedures.
- To oversee compliance during the design, construction, start-up, validation, and retirement of equipment, process, utilities, facilities, computer systems, etc.
- To be responsible for Quality Metrics development and monitoring compliance, internal/external audits etc.
Essential Requirements:
- Degree of equivalent in a life science.
- Extensive recent experience of QA leadership in a Pharma/CMO company.
- Excellent knowledge of global regulations, and experience of dealing with MHRA.
- Good communication skills internally and in a client facing role.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
