Director - Product Quality Complaints
Core
Leading the global product quality complaints program and serving as the Global Process Owner for the end-to-end complaints process across clinical and commercial products.
Role type
Director, Product Quality Complaints
Builds
Safe, compliant life-changing therapies for patients
Domain
Biopharmaceuticals / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global GMP principles, Quality Risk Management, Regulatory inspection readiness, Cross-functional leadership, Strategic process design, Data trend analysis
Preferred skills
cGMP/GDP/QSR/ISO 13485 knowledge, Pharmacovigilance interfaces, Statistical tools for signal detection
Technologies
Digital complaint management systems, Statistical analysis tools
Responsibilities
Lead global complaint intake, triage, investigation oversight, and closure; Ensure compliance with global regulations (21 CFR, EU GMP, ICH Q10); Drive robust complaint trending and signal detection; Maintain inspection readiness for FDA/EMA; Lead process reviews and governance forums; Coach and develop a team of quality professionals.
Seniority
Director, strategic leadership with hands-on process ownership
