Associate Director, Aseptic Product Quality
Core
Quality subject matter expert for aseptic manufacturing, leading due diligence at third-party manufacturers (TPMs/CMOs) and driving continuous improvement across the external manufacturing network.
Role type
Senior IC quality assurance leader (aseptic manufacturing)
Builds
Quality assurance strategies and risk mitigation frameworks for external manufacturing partners
Domain
Pharmaceutical manufacturing (aseptic/sterile)
Required skills
aseptic manufacturing assessment, due diligence, root cause analysis, corrective and preventive actions, regulatory inspection experience, risk evaluation, strategic planning, cross-functional collaboration
Preferred skills
plant experience in pharmaceutical setting, knowledge of biological/pharmaceutical technologies (sterile, liquid, ointments, devices, tablets, capsules, suspensions, granulations, APIs)
Technologies
aseptic manufacturing processes, contamination control systems, regulatory compliance frameworks
Responsibilities
Lead the Aseptic External & Product Quality Assurance Eye Care Global Team by developing and implementing aseptic strategies; 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, regulatory expectations, and industry trends; Provide quality oversight of external manufacturing operations to ensure compliance; Deliver strategic input and recommendations to support risk-based decision-making; Build and sustain collaborative relationships with internal manufacturing sites and global teams; Support the escalation, communication, and resolution of significant aseptic quality issues; Foster and promote a strong quality culture centered on proactive risk management.
Seniority
Senior, hands-on IC with leadership responsibilities