Manager - Quality Management Systems
Core
Ensuring compliance with FDA and regulatory requirements for biologics manufacturing through quality systems management, including deviations, CAPAs, and change controls.
Role type
Manager, Quality Management Systems
Builds
Biologics drug products and analytical services
Domain
Biopharma / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS) oversight, Investigation and CAPA management, Change Control program management, Deviation and OOS investigation, Regulatory compliance (FDA), Metrics reporting and analysis, Training development and delivery, Cross-functional team leadership, TrackWise system expertise
Preferred skills
None stated
Technologies
TrackWise
Responsibilities
Provide oversight to ensure Quality Systems compliance with regulatory and customer requirements; Account for Investigation and CAPA Management Systems and Change Control Program; Manage complex deviations and support OOS investigations; Maintain and enhance effectiveness of Quality System processes and procedures; Report and monitor site-wide metrics; Present Quality System status at quarterly reviews; Develop and provide training for personnel; Lead cross-functional teams for process improvement; Provide decision-making support in absence of QA Director
Seniority
Manager, hands-on IC
