QA Associate Director, Facility Operations 80-100% (f/m/d)
Core
Senior QA leadership for facility operations and pest control within the Contamination Prevention & Control (CPC) framework at a biologics manufacturing site.
Role type
Senior IC QA Associate Director (Facility Operations & Pest Control)
Builds
Reliable utility systems, robust facility interfaces, and effective pest control to enable GMP compliance and contamination prevention.
Domain
Biologics manufacturing / Pharmaceutical / GMP / Contamination Prevention
Required skills
GMP compliance, quality systems governance, risk-based decision making, deviation/CAPA/change control management, audit and inspection readiness, cross-functional stakeholder influence, contamination prevention principles, cleanroom operations, utility and infrastructure oversight.
Preferred skills
Utilities engineering, infrastructure qualification, pest control management, construction interfaces, project handover to operations.
Technologies
GMP quality systems, risk assessment tools, audit management systems
Responsibilities
Provide senior technical direction and QA oversight for site utility systems, facility operation, pest control, and construction interfaces; Own QA governance including deviation/CAPA review and trend analysis; Act as subject matter expert during regulatory inspections and customer audits; Drive continuous improvement of quality systems and inspection readiness.
Seniority
Senior, hands-on IC with leadership scope