Senior Manager, ECQ Delivery

Role: Senior Manager, Equipment Commissioning & Qualification (ECQ) Delivery, overseeing validation of equipment, facilities, and utilities at multi-use sites within a GMP environment. Responsibilities include managing validation teams, defining project strategies, developing SOPs, ensuring compliance with cGMP and regulatory standards, and overseeing requalification programs. Provides leadership for up to 50 staff, including hiring, training, performance management, and resource allocation. Acts as SME for audits and customer support, maintaining strong internal and external relationships. Qualifications: BS in Engineering or Science, 7+ years supporting pharmaceutical validation and managing personnel/projects, expert knowledge of GXP, GAMP, and 21CFR part 11, with strong project management, budget, and regulatory experience. Preferred skills include proficiency in computer systems validation, scheduling, and metrics analysis. High-Value: Focus on equipment and facility validation in a GMP setting, with regulatory audit exposure, supporting multi-disciplinary teams. Work setup: primarily office-based with GMP lab and facility access, no specific travel requirements detailed.