Manager, Quality Engineering, Change Control/Document Review
Core
Manage the change control quality process for all GMP activities and support the business process owner for the Change Control module at a cell therapy manufacturing facility.
Role type
Manager, Quality Engineering (Change Control)
Builds
Quality-compliant change control records and processes for cell therapy manufacturing
Domain
Pharmaceutical manufacturing / Cell therapy / GMP compliance
Required skills
cGMP manufacturing experience, Quality and Compliance expertise, Change Control process management, Technical writing and report generation, Risk management principles, Process improvement, Data analysis, Cross-functional stakeholder management, Inspection support
Preferred skills
Advanced computer skills, Decision-making, Problem solving, Conflict management, Coaching
Technologies
GMP systems, Change Control modules
Responsibilities
Review and approve change controls and associated documents for regulatory compliance, Drive process improvement initiatives, Support internal and health authority inspections, Communicate effectively with cross-functional stakeholders, Prepare written communications and data analysis for management, Resolve quality issues and propose solutions
Seniority
Manager, hands-on IC with strategic influence