Director, QA Operations (Quality Events and Data Analytics)
Tustin, California, United States
USD 165K-207K Executive-level Full Time
Tasks
- Communicate with clients to support issue resolution and client relations
- Develop and manage quality personnel training motivation and appraisal
- Develop quality event KPIs and perform analytical trending
- Identify design and implement process improvements using operational excellence tools
- Implement preventive actions to minimize rate of controllable quality events
- Manage QA team review and approval of deviation CAPA OOS and complaints
- Oversee quality event process execution and continuous improvement
- Present analytics to governance meetings
- Provide QA oversight and guidance to real time manufacturing floor events
- Remediate events to ensure compliance with cGMP expectations
Perks/Benefits
- N/A
Skills/Tech-stack
Biologics manufacturing | Black Belt | CGMP | Cause analysis | Change Control | Complaint handling | Corrective and Preventive Actions | Deviation Management | Document Control | Excel | Management System | OOS Investigation | Operational excellence | Out of Specification | Out of Specification Investigations | PowerPoint | Preventive Action | Preventive actions | Process Improvement | Quality Events | Quality Events KPIs | Quality Management System | Quality Risk Management | Quality management | Risk Management | Root Cause Analysis | Root cause | Six Sigma | Statistical Analysis | Word
Education
Roles
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