Senior Manager, ECQ Delivery
Core
Senior Manager leading Equipment Commissioning & Qualification (ECQ) teams to validate pharmaceutical manufacturing and laboratory equipment, facilities, and computerized systems in compliance with cGMP and GXP regulations.
Role type
Senior Manager, Equipment Commissioning & Qualification (ECQ)
Builds
Validated equipment, facilities, and computerized systems for pharmaceutical manufacturing and laboratory functions
Domain
Pharmaceutical manufacturing / Laboratory operations / Computerized System Validation (CSV)
Required skills
cGMP/GXP/GAMP/21CFR Part 11 knowledge, pharmaceutical manufacturing systems expertise, team leadership (50+ people), budget management, project scheduling, CAPA management, regulatory compliance, stakeholder communication
Preferred skills
Experience with CMMS, database systems, enterprise business tools, change strategy, risk assessment
Technologies
Microsoft Office Suite, CMMS, database systems, enterprise business tools
Responsibilities
Manage ECQ teams and resources for equipment validation; Define technical strategy and project lifecycles; Oversee SOP/WP/test protocol development; Ensure regulatory compliance and audit readiness; Lead hiring and performance reviews; Manage departmental budgets and metrics; Provide technical support and customer service for qualification requests
Seniority
Senior Manager, hands-on leadership