Sr. Manager, Quality
Core
Guide strategic quality initiatives and ensure regulatory compliance across pharmaceutical, medical device, or regulated life sciences operations.
Role type
Senior Manager, Quality
Builds
Quality management systems and regulatory compliance frameworks
Domain
Regulated life sciences / Pharmaceutical / Medical Device
Required skills
Quality management systems (QMS), GMP, ISO 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR, CAPA, change control, FMEA, risk analysis, root cause analysis, regulatory inspection hosting, data analysis, project management
Preferred skills
ASQ certification, Lean Six Sigma, Science/Engineering/Chemistry degree
Technologies
Quality management software systems
Responsibilities
Oversee quality management systems and ensure regulatory compliance, manage quality assurance and control teams, lead investigations and implement data-driven solutions, develop quality professionals, host regulatory inspections and customer audits, guide process improvements using PPI methodologies
Seniority
Senior, hands-on IC with leadership responsibilities
