Manager, Quality COE - Lab Support SDLC
Core
Lead a team of quality specialists to manage Laboratory System Qualification, ensuring high standards of quality and compliance in pharmaceutical manufacturing.
Role type
Manager, Quality COE - Lab Support SDLC
Builds
Laboratory system lifecycle management, qualification, retirement, commissioning, decommissioning, calibration, and maintenance.
Domain
Pharmaceutical Manufacturing / Quality Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Laboratory system lifecycle management, Budget management, Regulatory compliance (Singapore/EU/US), Change management, Project management, Team leadership, Financial budget control, Inspection readiness, Corrective action management, GMP documentation
Preferred skills
Analytical method transfer, LIMS, Instrumentation calibration, Periodic reviews, Quality initiatives, Technical writing
Responsibilities
Oversee Quality initiatives to improve compliance, efficiency, and cost savings; Manage MRO and CAPEX budgets; Ensure inspection readiness for internal/external audits; Plan and manage resource utilization; Train and develop direct reports/contractors; Manage escalations and communicate with senior stakeholders; Drive cultural transformation; Review and approve quality documentation (change control, deviations, protocols).
Seniority
Manager, hands-on IC with team leadership
