Manager, Quality Assurance
Core
Oversees quality assurance activities for business operations units, ensuring compliance with FDA regulations, ISO requirements, and quality management systems.
Role type
Manager, Quality Assurance (Manufacturing)
Builds
Quality Management System (QMS) compliance and operational reliability for manufacturing units
Domain
Life Sciences / Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA regulations knowledge, ISO standards, CAPA program management, internal auditing, root cause analysis, cGMP compliance, process documentation, supplier management, strategic insight
Preferred skills
Supervisory experience, life science degree, advanced quality courses
Technologies
MS Word, Excel, PowerPoint, Access
Responsibilities
Manage and direct the Quality Assurance department and associates; Conduct internal audits for the Quality Management System; Lead Complaint Investigation efforts; Maintain and manage cGMP compliance; Coordinate objectives with production procedures; Ensure inspection activity for products throughout the production cycle
Seniority
Manager, supervisory level
