Director Quality Assurance, Drug Substance Manufacturing
Core
Lead the startup and long-term operations of a greenfield biologics manufacturing facility, building the QA organization and digital processes for a fully automated plant.
Role type
Director, Quality Assurance (Manufacturing)
Builds
A new, fully automated biologics manufacturing facility (greenfield site) in Saratoga Springs, NY.
Domain
Biologics / Drug Substance Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Operations, Quality Management, cGMP biologics manufacturing, facility startup, commissioning, qualification, process validation, leadership, automation systems (MES, DCS/SCADA), data integrity, review-by-exception models
Preferred skills
Cell culture, centrifugation, chromatography, UFDF, aseptic dispensing operations
Technologies
MES, DCS/SCADA, historian, LIMS
Responsibilities
Lead QA startup strategy including quality systems build-out, staffing, and readiness for design review and validation; Define automation and data integrity requirements for review-by-exception batch disposition; Build and maintain a high-performing team of managers; Establish data integrity governance ensuring ALCOA+ principles and 21 CFR Part 11/Annex 11 compliance; Provide first response for Quality and Compliance issues on the manufacturing floor; Represent the company during regulatory body inspections; Lead cross-functional teams to manage project deliverables within timeline and budget; Ensure manufacturing quality staff are trained to support a highly automated environment.
Seniority
Director, strategic leadership with hands-on operational oversight
