Associate Quality Manager, Stability
Core
Lead and advance a best-in-class Stability program ensuring compliance with global regulatory requirements (ICH, FDA, ISO) and inspection readiness for the product lifecycle.
Role type
Associate Quality Manager, Stability
Builds
Stability programs, study designs, and regulatory submissions for medical devices
Domain
Medical Devices / Pharmaceutical Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical stability testing, ICH and global regulatory standards, analytical techniques, instrumentation, complex data analysis, statistical principles, quality system improvements
Preferred skills
Supervisory experience, people leadership, mentoring, ASQ CQE Certification, cross-functional stakeholder communication
Technologies
ICH, FDA, ISO, analytical instrumentation
Responsibilities
Lead stability study design, execution, monitoring, and reporting; establish and improve stability policies and procedures; analyze stability data and trends to identify risks; plan and oversee team deliverables; partner cross-functionally with Quality, Regulatory, R&D, Manufacturing, and Supply Chain; build and lead high-performing teams
Seniority
Mid-level, hands-on IC with team leadership
