Senior Director, Site Head of Quality
Core
Lead the site Quality organization (100-200 HC) to drive a Patient First culture, ensure conformance with cGMP, and manage critical deviations and CAPA for biologics manufacturing.
Role type
Senior Director, Site Head of Quality
Builds
Biologics drug substance and drug product manufacturing operations
Domain
Biopharma / Biologics Manufacturing
Required skills
Biologics manufacturing leadership, cGMP compliance, Quality Management System (QMS) implementation, budget management, regulatory interpretation (FDA/EMA), talent development, deviation/CAPA management
Preferred skills
Drug product manufacturing experience, matrix organization leadership, Catalent internal leadership program experience
Technologies
QMS, cGMP regulatory frameworks
Responsibilities
Lead the site Quality organization and drive a Patient First culture; Champion the Quality Management System (QMS) and ensure strong technical capability; Staff the Quality team and create succession pipelines; Define and execute quality budgets; Ensure metrics and reporting processes drive operational execution; Drive remediation for quality performance; Oversee critical deviations and CAPA plans
Seniority
Senior Director, Site Head