Manager/Senior Manager Quality Assurance
Core
Overseeing day-to-day operations of the Quality Assurance team to ensure quality and compliance with Federal and State regulatory requirements, including audits, inspections, and trend analysis.
Role type
Manager/Senior Manager Quality Assurance (Regulatory Compliance)
Builds
Quality systems and processes for clinical laboratory testing services
Domain
Life sciences / Clinical laboratory testing / Regulatory compliance
Deliverable
client delivery
Required skills
Regulatory compliance (CAP/CLIA/GxP), audit management, SOP creation, performance management, process improvement, data integrity, mentoring, trend analysis
Preferred skills
Six Sigma, strategic planning, budget input, cross-functional leadership
Technologies
Excel, PC-based software
Responsibilities
Oversee daily QA operations and provide direction to associates; conduct audits and host client/regulatory inspections; review/approve time sheets and performance reviews; create/revise SOPs; communicate on audits, deviations, and CAPAs; implement process improvements to minimize waste; mentor associates on quality outcomes and data analysis; resolve deficiencies and ensure corrective actions; identify gaps in laboratory testing and optimize processes for compliance
Seniority
Senior, hands-on IC (Manager) / Senior, strategy & mentorship (Senior Manager)