Senior Manager, ECQ Delivery
Core
Senior Manager leading Equipment Commissioning & Qualification (ECQ) teams to validate new equipment, facilities, and computerized systems in a GMP-compliant pharmaceutical environment.
Role type
Senior Manager, Manufacturing Operations (ECQ)
Builds
Validated equipment and computerized systems for multi-use pharmaceutical facilities
Domain
Pharmaceutical manufacturing / GMP compliance
Required skills
GMP/cGMP/GXP/GAMP knowledge, System Lifecycle management, Budget management, Team leadership (50+ people), Regulatory audit leadership, CAPA management, Project scheduling
Preferred skills
CMMS experience, Database systems proficiency, Change strategy development
Technologies
Microsoft Office Suite, CMMS, Enterprise business tools
Responsibilities
Manage ECQ teams and resources for validation activities, Define technical strategy and project lifecycles, Oversee SOP/WP/test protocol development, Lead audits and ensure regulatory compliance, Manage departmental budgets and metrics, Provide technical support and customer service for qualification requests
Seniority
Senior, hands-on IC with management responsibilities