Senior Manager, QMS Process Improvement and Analytics
Tasks
- Coordinate with Quality Technical Operations and Regulatory teams for alignment and continuous improvement
- Define track and analyze QMS KPIs
- Ensure audit and inspection readiness for QMS documentation
- Identify trends and recommend actions to improve process performance
- Improve right first time execution of quality records
- Improve technical accuracy and clarity of QMS documentation
- Lead cross functional improvement projects to streamline QMS workflows
- Provide KPI summaries for governance meetings
- Review and enhance QMS policies and enterprise SOPs
- Support QMS process implementation and maintenance
- Support digital transformation for QMS tools automation and analytics
- Support root cause analysis and compliant documentation
Perks/Benefits
- 401k
- Dental insurance
- Employee stock purchase plan
- FSA/HSA
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
- Wellness programs
Skills/Tech-stack
Audit Readiness | Automation | Cause analysis | Change Control | Complaint handling | Corrective and Preventive Action | Data analytics | Deviation Management | Digital Transformation | Document Management | Document Review | EMA regulations | Electronic QMS | Excel | FDA Regulations | GxP Surveillance | ICH Q10 | ISO 13485 | ISO 9001 | Key Performance Indicators | Lean | MS Office | Management Review | Management System | Outlook | Performance indicators | PowerPoint | Preventive Action | Process Improvement | Quality Management System | Quality management | Regulatory Compliance | Root Cause Analysis | Root cause | Six Sigma | Smartsheet | Technical writing | TrackWise | Training Management | Veeva | Word
Education
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