Aseptic Product Quality Associate Director
Core
Quality leadership for aseptic manufacturing, focusing on due diligence at third-party manufacturers (TPMs/CMOs), risk mitigation, and continuous improvement across the external manufacturing network.
Role type
Senior IC quality assurance leader (aseptic manufacturing)
Builds
Quality assurance strategies and operational performance for external manufacturing partners
Domain
Pharmaceutical manufacturing (aseptic/sterile)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
aseptic manufacturing assessment, root cause analysis, corrective and preventive action development, regulatory inspection experience, risk evaluation, strategy development, crisis management, cross-functional collaboration
Preferred skills
plant experience in pharmaceutical settings, knowledge of biological and pharmaceutical technologies (sterile, liquid, ointments, devices, solid tablets, capsules, suspensions, granulations, gel caps, extended release products, coating solutions, APIs)
Technologies
aseptic manufacturing processes, contamination control systems, regulatory compliance frameworks
Responsibilities
Conduct due diligence visits to prospective external partners (TPMs/CMOs). Perform hands-on assessments of aseptic manufacturing operations, processes, and controls. Provide technical quality leadership for aseptic-related investigations. Monitor and evaluate emerging technologies and regulatory expectations. Deliver strategic input for risk-based decision-making. Support the escalation and resolution of significant aseptic quality issues.
Seniority
Senior, hands-on IC with strategic oversight