Quality Operations Supervisor (API)
Core
Supervise API Quality Operations specialists to maintain quality systems for API manufacturing, ensuring compliance with AbbVie policies and cGMP across manufacturing, warehouse, QC, and IT.
Role type
Senior IC Quality Operations Supervisor (API Manufacturing)
Builds
API manufacturing operations compliant with cGMP
Domain
Pharmaceutical manufacturing (API)
Required skills
cGMP compliance, batch record review and release, change management, root cause analysis, SOP development and approval, NPI quality oversight, team supervision and mentoring, regulatory knowledge (GxP), problem-solving, planning and scheduling
Preferred skills
Cross-functional collaboration, continuous improvement initiatives, audit preparation, FMEA updates, annual product quality review leadership
Technologies
MES, CP framework, QO systems
Responsibilities
Supervise team of Quality Operations Specialists; oversee batch record review and release; manage change control and NPI quality; lead root cause analysis and corrective/preventive actions; mentor staff on cGMP and quality systems; coordinate with global counterparts on compliance; present technical issues to management.
Seniority
Senior, hands-on IC with supervisory duties
