Regional Quality Manager - Salt Lake City, UT (On-site)
Core
Ensures quality management system compliance, audit execution, and regulatory adherence across a region of laboratories.
Role type
Senior Quality Manager (Laboratory Operations)
Builds
Compliance with ISO 17025, FDA regulations, and internal quality standards for analytical testing sites.
Domain
Life Sciences / Laboratory Testing / Regulatory Compliance
Deliverable
client delivery
Required skills
ISO 17025 compliance, FDA regulatory knowledge (21 CFR), audit execution, root cause analysis, CAPA management, LIMS usage, technical writing, risk analysis, equipment qualification, method validation
Preferred skills
Production style laboratory experience, QA/QC program experience, training and auditing experience
Technologies
LIMS
Responsibilities
Supervise up to 5 direct reports and local quality specialists; conduct annual laboratory assessments and quality management reviews; coordinate and host client/regulatory audits; monitor non-conformances and trends; execute proficiency testing programs; report monthly metrics to the group.
Seniority
Senior, hands-on management with direct reports