Quality Assurance Manager
Core
Provide quality assurance support for pharmaceutical, medical device, and biologics manufacturing processes, ensuring compliance from raw material inspection to final shipment.
Role type
Senior IC Quality Assurance Manager
Builds
compliant manufacturing processes and quality systems for pharmaceutical and medical device products
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory compliance (FDA/EMA/ICH), CAPA management, deviation investigation, staff leadership, quality policy development, GMP knowledge, cross-functional team leadership
Preferred skills
technical knowledge in process sciences, familiarity with pharmaceutical/biological product facilities, project management for complex initiatives
Technologies
GMP systems, Document Center, Quality Intelligence tools, Compendia management platforms
Responsibilities
Direct staff hiring, performance feedback, and development; Develop and maintain quality policies; Interface with FDA and regulatory agencies during inspections; Assess compliance to identify gaps and implement improvements; Review and approve deviation investigations; Compile and communicate quality metrics to senior management; Establish programs to promote quality awareness.
Seniority
Senior, hands-on IC with strategic oversight
