Senior Clinical Lab QA Lead - Quality & Compliance

Abbott Laboratories; Madison (WI); On-site; USD 87,000 - 173,000; Full time

Job summary

The Lead Clinical Lab QA Specialist at Abbott Laboratories will develop, implement, and maintain the Quality Management System for Exact Sciences Laboratories, ensuring regulatory compliance and driving continuous improvement.

They will lead cross-functional projects, guide lab QA teams, and coordinate with internal and external partners while traveling as needed and maintaining confidentiality.

Qualifications

• Bachelor’s degree in a scientific major or related field.
• 4+ years of professional work experience in quality assurance in a regulated environment.
• 2+ years of direct experience leading process/project implementations or improvements.
• Familiarity with FDA, CLIA, CAP, HIPAA or related regulations.
• Proficient with Epic or other ePHI software.
• Strong communication and collaboration across functions.

Responsibilities

• Develop, implement, and maintain the Quality Management System for Exact Sciences Laboratories.
• Monitor effectiveness of the quality system and drive continuous improvement.
• Provide guidance to QA teams and other lab groups while leading through influence.
• Investigate and resolve complex QA concerns from internal and external partners.
• Lead cross-functional projects with internal and external stakeholders.
• Travel between work locations as required and maintain confidentiality.

Skills

Attention to detail

Cross-functional collaboration

Strong communication

Project management

Regulatory knowledge

Education

Bachelor’s degree in a scientific field

Advanced degree in a scientific field

Tools

Epic EHR

Microsoft Office

Job description

The Lead Clinical Lab QA Specialist at Abbott Laboratories will develop, implement, and maintain the Quality Management System for Exact Sciences Laboratories, ensuring regulatory compliance and driving continuous improvement.

They will lead cross-functional projects, guide lab QA teams, and coordinate with internal and external partners while traveling as needed and maintaining confidentiality.