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Quality Operations Project Associate
3 weeks ago
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 on-time 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
- Co-ordinate/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)
**Job Types**: Full-time, Fixed term contract, Freelance
Contract length: 12 months
**Salary**: £35,000.00-£40,000.00 per year
**Benefits**:
- Flexitime
- Work from home
Schedule:
- Flexitime
- Monday to Friday
Ability to commute/relocate:
- Uxbridge: reliably commute or plan to relocate before starting work (required)
**Education**:
- Bachelor's (preferred)
Work Location: Hybrid remote in WIRRAL
Reference ID: QAOP
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