Quality Project Manager

ZipRecruiter; Liverpool; Hybrid; GBP 40,000 - 80,000

Job description

Job Description

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

Company: A Global Biopharmaceutical Company

Job Description:

Justification:

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.

Job Summary:

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.

This Role:

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.

Key Responsibilities:

• Manage and support the External QP release process
• Coordinate and align all required documentation
• Address any QP-related queries
• 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

Qualifications & Experience:

• Degree-qualified or equivalent experience required
• At least 2 years of previous Quality experience, ideally from a pharmaceutical GMP environment
• Project Management/Coordination experience is essential
• Experience with Investigational Medicinal Products (IMPs)
• Strong understanding of QP process and requirements
• Trackwise/Veeva experience is a big plus
• Demonstrated experience leading continuous improvement initiatives or implementing new ways of working
• Ability to build and leverage relationships with a broad focus within the function
• Knowledge of clinical trial documentation submission and approval processes
• Experience in process improvement
• Strong knowledge of computer systems (MS Office, Excel, Word, etc.)
• Ability to coordinate and lead meetings