Quality Assurance Manager
Core
Oversee and advance quality systems and standards, ensuring compliance with customer, regulatory, and internal QMS requirements for printing regulated products.
Role type
Senior IC Quality Assurance Manager
Builds
Sustainable compliance to customer, regulatory, and RR Donnelley QMS requirements
Domain
Manufacturing / Quality Management / Regulated Industries (Food Safety, Medical Device, Pharma)
Required skills
Quality Management System (QMS) management, GMP compliance (21 CFR Part 820), ISO 9001:2008, root cause analysis, CAPA management, internal auditing, regulatory interpretation, Microsoft Office Suite
Preferred skills
Advanced training in cGMPs, experience with food safety/medical device/pharma GMPs, supervisory experience
Technologies
Quality Task Tracker, Microsoft Office Suite (Word, Excel)
Responsibilities
Maintain and improve site QMS and processes, ensure QMS compliance with regulatory requirements, coordinate certification compliance audits, facilitate root cause analysis and corrective/preventive actions, monitor QMS process trends, evaluate QMS process effectiveness, collect and report quality metrics, interact with customers on quality responses, review GMP documents for compliance, lead internal process verification audits, manage quality department employees, ensure deviation investigations are recorded, drive CAPA items to completion
Seniority
Senior, hands-on IC with supervisory experience