Role: Quality Project Manager Contract: 12 Month Contract Initially with the possibility of extension! Full-time
Location: Hybrid with 3 days in the office in greater Liverpool area
A new position of Quality Project Manager has been created to support the External Manufacturing Quality team, due to the insourcing of newly acquired clinical trials.
The Product Development Quality (PDQ) team, operating under Good Manufacturing Practice (GMP) guidelines, oversees the manufacture, testing, and distribution of clinical supplies (investigational products). This ensures quality and compliance with GMP and other relevant regulations and internal procedures. Key responsibilities include drug product batch disposition (release/reject decision), Investigational Medicinal Product (IMP) certification and release by the External Manufacturing Quality team, auditing of internal GMP systems/processes and suppliers/third-party contractors, and assisting stakeholders with regulatory advice and preparation for, and management of, regulatory agency inspections.
The Project Manager will be responsible for prioritizing and aligning the external Qualified Person (QP) release of clinical supplies at Contract Manufacturing Organizations (CMOs). The role will involve collaboration with Regulatory Affairs and Global Clinical Supply Chain to ensure timely delivery of Health Authority approvals for clinical supply releases, as applicable.
Liaise with Trials Supplies Management (TSM), Trial Managers (TM), Regulatory CMC QA, Regulatory Affairs, and Product Development Quality teams
Identify dependencies, evaluate risks, and communicate project status to management and stakeholders
Ensure project deliverables and schedules are met, adhering to established standards
Proactively address obstacles to maintain project momentum
Plan and engage necessary resources to ensure successful project completion
Advise and consistently apply best practices and tools for Project Management
At least 2 years of previous Quality experience, ideally from a pharmaceutical GMP environment
Project Management/Coordination experience is essential
Strong knowledge of computer systems (MS Office, Excel, Word, etc.)