Quality Operations Project Associate - Wirral, United Kingdom - Ark Talent Group

Ark Talent Group

Verified Company

Wirral, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Quality Operations Project Associate

Contract 12 months

Hybrid (50% working from home and 50% in Moreton, Wirral)

Our client is looking for a Quality Operations Project Associate to support the Quality Team due to the insourcing of heritage Celgene clinical trials.

The key responsibilities will include:

Drug product batch disposition (release/reject decision)
Investigation Medicinal Product Certification and release by the UK Qualified Person
Audit of internal GMP systems/processes and suppliers/third party contractors
Assist stakeholders with regulatory advice and preparation for and management of regulatory agency inspections
Serves as a Project Manager for prioritizing and alignment of external Qualified Person (QP) release of clinical supplies at Contract Manufacturing Organisations (CMOs)
Partner with Regulatory Affairs to ensure ontime delivery of Health Authority approvals for release of clinical supplies (as applicable)
Support the PDQ function at Moreton to ensure timely release of Investigational Medicinal Products (IMPs), as applicable
Project Manage/support the External QP release process
Coordinate/align on all required documentation
Triage/answer any QP related queries
Liaise with Trials Supplies Management (TSM), Trial Managers (TM) and Regulatory Affairs
Identify dependencies, evaluate risks, and communicate status to appropriate levels of management and stakeholders across the business
Ensure project deliverables and schedules are met, adhere to established standards, which are managed in alignment with BMS Project Management best practices across their assigned projects
Proactively remove obstacles to drive assigned project's momentum and progress
Plan and engage necessary resources across the enterprise to ensure successful completion of assigned projects
Support the PDQ function at Moreton to ensure timely release of Investigational Medicinal Products (IMPs)