Associate Director, Project Quality - QC
Core
Provide strategic and operational leadership for Quality Control (QC) activities supporting the design, qualification, validation, and operational readiness of a new Immunoglobulin (Ig) manufacturing facility expansion.
Role type
Senior IC Associate Director, Project Quality Control
Builds
New IgG manufacturing facility (Module 7/8) at CSL Kankakee site
Domain
Biopharmaceutical manufacturing / Immunoglobulin production
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (manufacturing facility qualification and readiness)
Required skills
Laboratory management, GxP regulations, analytical methods development, risk mitigation, project governance, change control, regulatory inspection support, team leadership, process validation, equipment qualification
Preferred skills
Advanced degree in scientific discipline, Six Sigma, Lean, variability reduction, global matrix organization experience
Technologies
Analytical instruments, cGMP systems, laboratory information management systems (implied by context of QC)
Responsibilities
Lead QC activities for facility design reviews, user requirements, and laboratory fit-out; Manage QC timelines, budgets, and resources for project delivery; Develop operational readiness plans including staffing and training; Oversee change control for analytical methods and quality processes; Mitigate project risks impacting QC deliverables and qualification timelines.
Seniority
Senior, hands-on IC with direct reports