Quality Compliance Specialist (Quality Risk Management)
Core
Support Internal Drug Product Manufacturing operations by applying patient-centered quality risk management (QRM) across processes like change control and deviation management.
Role type
Quality Compliance Specialist (Quality Risk Management)
Builds
Quality risk assessments, risk reviews, and QRM programs for manufacturing operations.
Domain
Pharmaceutical manufacturing / Quality Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality risk management principles, FMEA, RBIA, REM, HACCP methodologies, cross-functional facilitation, technical data interpretation, continuous improvement metrics
Preferred skills
Veeva platform proficiency, contamination control strategy (CCS) knowledge, aseptic processing risk assessment
Technologies
Microsoft Word, Excel, PowerPoint, Veeva
Responsibilities
Facilitate data-driven risk assessments and reviews, define risk assessment scope and criteria, guide teams through risk identification and mitigation, prepare and revise QRM documents, support regulatory and internal audits, coach colleagues on QRM principles, track risk review metrics.
Seniority
Specialist (2+ years) to Senior Specialist (5+ years)
