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) Delivery
Builds
Validated equipment, facilities, and computerized systems for pharmaceutical production and research
Domain
Pharmaceutical manufacturing and laboratory operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP/GXP/GAMP/21CFR part 11 knowledge, pharmaceutical manufacturing systems expertise, team leadership and hiring, budget and resource management, SOP/WP/protocol development, regulatory audit leadership, project lifecycle strategy, risk assessment and CAPA management, stakeholder communication
Preferred skills
Experience with CMMS and scheduling software, database systems proficiency, capital budget forecasting
Technologies
Microsoft Office Suite, CMMS, corporate intranet, enterprise business tools
Responsibilities
Manage ECQ teams and allocate resources for validation activities, define technical strategy and project lifecycles, oversee SOP and test protocol development, ensure compliance with global policies and regulatory requirements, lead audits and manage investigations/deviations, develop and manage departmental budgets, hire and develop personnel, provide technical support to internal customers
Seniority
Senior Manager, hands-on leadership with up to 50 direct/indirect reports
