Quality Manager - Job ID:4495
- Host partner audits and regulatory agency inspections.
- Act as Change Control Manager/Coordinator and subject matter expert, facilitate all change control meetings and activities, and assure change control activities are performed in a compliant, timely and contentious manner.
- Act as Deviation/Event process subject matter expert and facilitate deviation/event management.
- Coordinate completion of Annual Product Quality Reviews (APQRs) by facilitating consolidation/summarization of internal and contractor data. Assure timely completion and communication in alignment with Cubist procedures and Quality Agreements.
- Coordinate Technical Quality Agreement completion by facilitating meetings with internal and external stakeholders in alignment with Cubist Quality policies and procedures.
- Act as Product Complaint Manager/Coordinator and subject matter expert, facilitate all Complaint Review Board Meeting meetings and activities, and assure activities are performed in a compliant, timely and contentious manner.
- Introduce new and innovative approaches to continually improve our quality systems and practices.
- Monitor quality metrics. Troubleshoot issues and support metrics improvements related to Change Control, Deviations/Events/CAPAs, and APQRs.
- Participate in or lead Quality System improvement project teams as required.
- Improve and manage the corrective action / preventive action (CAPA) process and systems to assure elimination of root causes and timely response to identified issues.
- Bachelor's degree and 9 + years of cross functional responsibility in Quality Systems.
- Demonstrated ability to work efficiently under conditions of multiple deadlines and changing priorities.
- Excellent understanding of pharmaceutical regulations.
- Proficiency with MS Office and software programs for generating reports, presentations and statistics
- Proficiency with TrackWise.