Job Summary:
The External Manufacturing Operations Coordinator role is a key member of the Global External Manufacturing Operations team, providing critical support to ensure the seamless production and supply of clinical and commercial drug products through contract manufacturing organizations (CMOs). This role focuses on executing ERP and QMS transactions, supporting cross-functional teams, and contributing to continuous improvement initiatives.
Responsibilities:
- Support Process Team Leads across Clinical, Small Molecule, Biological, and Packaging operations.
- Manage ERP system transactions (e.g., production entries, PO receipting, inter-org transfers).
- Own and drive timely closure of change controls within the Quality Management System (QMS).
- Prepare and issue performance metrics and support data reporting needs.
- Provide backup support to Process Team Leads and assist in eliminating redundant task touchpoints.
- Participate in root cause analysis and implement corrective actions.
- Support continuous improvement projects aligned with site goals.
- Document business processes in standardized formats (e.g., SOPs or Best Practice Documents).
Qualifications:
- Bachelor's degree in a relevant field.
- 3-5 years of experience in Operations or Supply Chain within a regulated environment.
- Working knowledge of ERP systems (Oracle or SAP preferred).
- Familiarity with lean, Six Sigma, or other continuous improvement methodologies.