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Quality Operations Manager
2 months ago
We are seeking a highly motivated Quality Operations Manager to lead and coordinate the Quality Operations team at Iovance Biotherapeutics Inc. The Quality Operations team will be responsible for ensuring that all operations comply with cGMP regulations and internal policies and procedures.
Key Responsibilities:
- Lead the Quality Operations team, ensuring daily support for all manufacturing activities and interfacing with functional groups to determine events and report to management.
- Review batch records and related production documentation, ensuring resolution of all identified issues prior to product disposition.
- Disposition incoming raw materials and final product release.
- Issuance of batch records and labels.
- Assist with investigation of manufacturing deviations, OOS results, temperature excursions, and other non-conformances.
- Apply quality compliance theories and principles to independently address a variety of issues of moderate scope.
- Maintain and report on Quality Metrics.
Requirements:
- A Bachelor's Degree in Science, Engineering, or a related technical discipline.
- At least 8 years of experience in the pharmaceutical industry in an aseptic manufacturing environment.
- Knowledge of cGMP regulations.
- Skilled in use of Microsoft Word, Excel, and PowerPoint.
- Familiarity with QMS systems.
- Supervisory experience is a plus.
