Manager, QMS
Core
Lead the site Quality Management System portfolio, overseeing investigations, customer complaints, change control, APQR, and management review to ensure regulatory compliance and operational excellence.
Role type
Senior IC Quality Management System Program Leader
Builds
Quality governance frameworks, risk-based priorities, and inspection readiness for regulated manufacturing
Domain
Pharmaceutical/Medical Device Manufacturing
Required skills
Quality system governance, cGMP regulations, investigations management, CAPA, customer complaints handling, change control, quality risk management, data integrity, complex data analysis, regulatory inspection readiness
Preferred skills
Advanced degree in science/engineering, experience with FDA/Health Canada inspections, proficiency in eQMS (TrackWise), analytics tools (Power BI, Tableau, Smartsheet), Six Sigma Black Belt, CMQ/OE, CQA, CQE certifications
Technologies
TrackWise, Power BI, Tableau, Smartsheet, Excel
Responsibilities
Lead the site QMS portfolio and governance frameworks, drive analysis of quality data and trends, partner with cross-functional teams (Manufacturing, Engineering, RA, etc.), develop and coach Quality professionals, monitor performance via scorecards, represent quality systems during audits and inspections
Seniority
Senior, hands-on IC with leadership responsibilities
