Director, Quality & Compliance - Clinical Lab

Regulatory Jobs; Cleveland (OH); On-site; USD 120,000 - 180,000; Full time

Job summary

Regulatory Jobs is seeking a Director of Quality to lead the Quality Assurance function and the CA CLS Limited License Training Program. You will coordinate QA activities, drive quality systems, and ensure compliance with federal and state laboratory regulations.

The role reports to senior leadership and collaborates across the business unit. The ideal candidate has 10+ years in clinical lab settings, strong leadership, and regulatory expertise.

Qualifications

• 10+ years in a Clinical Laboratory setting.
• 5+ years of demonstrated leadership and management responsibilities.
• 3+ years in a Regulatory Environment or knowledge of state/federal requirements.

Responsibilities

• Coordinate and direct all functions of Quality Assurance.
• Oversee Quality Improvement System, state licensure, and training program.
• Lead audits related to ISO, CAP, and regulatory agencies.
• Ensure training competency and document control across the unit.
• Develop scorecard metrics and management review documentation.
• Respond to customer feedback and drive continuous improvement.
• Advise leadership on quality status and non-conformities.
• Manage quality staff and lead a team of direct and indirect reports.

Skills

Quality Improvement

Communication skills

Independent work

Cross-functional collaboration

Education

Bachelor’s Degree

Master’s Degree or PhD or MBA

Job description

Regulatory Jobs is seeking a Director of Quality to lead the Quality Assurance function and the CA CLS Limited License Training Program. You will coordinate QA activities, drive quality systems, and ensure compliance with federal and state laboratory regulations.

The role reports to senior leadership and collaborates across the business unit. The ideal candidate has 10+ years in clinical lab settings, strong leadership, and regulatory expertise.