Senior Manager, GMP OT Applications
Core
Manage the Automation group overseeing configuration, installation, and support of biopharmaceutical process and QC laboratory equipment while driving automation projects and regulatory compliance.
Role type
Senior Manager, Manufacturing Automation
Builds
Biopharmaceutical process and QC laboratory equipment automation solutions
Domain
Biopharmaceutical manufacturing and laboratory operations
Required skills
cGMP biotech and pharma operations, regulatory and quality policies, Software Design Lifecycle, Quality Risk Management, project management, data integrity management
Preferred skills
technical advisor capabilities, cross-functional leadership, senior management presentation
Responsibilities
Manage automation projects for process equipment and laboratory software, serve as Subject Matter Expert during regulatory inspections, develop procedures for automation projects, coach and develop personnel, support Manufacturing, QC, and Maintenance as technical advisor
Seniority
Senior Manager, 8+ years experience with 5+ years supervisory