Senior Manager/ Associate Director of Quality Anal…
Greater Boulder Area
3 days ago
The Senior Manager/ Associate Director of Quality Analytical Services will establish, oversee and manage quality analytical services under good manufacturing practice operations to include quality control testing, test method validation, stability program, and laboratory management. S/he will provide leadership to establish and maintain quality levels that meet and exceed customer expectations in the laboratory in compliance with US FDA Regulations and ISO 13485:2016 standards. Function includes management and oversight over the Quality Control departments, test method validation program, and stability program; assurance that relevant procedures are managed and continuously reviewed and improved for compliance and operating efficiencies; ensuring department personnel are trained; ensures compliance to medical device and in vitro diagnostic regulations, relevant to the scope of department.