Lead Clinical Lab QA Specialist

Position Overview
The Lead Clinical Lab QA Specialist is responsible for the development, implementation, administration, and maintenance of the Quality Management System for the Exact Sciences Laboratories. This role is also responsible for ensuring compliance with all clinical laboratory regulatory requirements. The Lead Clinical Lab QA Specialist will monitor the effectiveness of the quality management system, identify, support, and facilitate continuous improvement opportunities and educate the workforce on applicable procedures and regulations.

Essential Duties
Include, but are not limited to, the following:

• Independently manage multiple, complex projects simultaneously within defined timelines, prioritizing as necessary, with minimal instruction or oversight.

• Identify, develop, design, and assist with coordinating improvements.

• Provide subject matter expertise, guidance, and recommendations to Lab QA team members and other Exact Sciences Lab teams/sites while leading through influence, informal leadership, and best practice advocacy.

• Investigate, document, and resolve complex quality assurance related concerns received from various lab teams, enterprise teams, and 3rd party vendors.

• Utilize project management experience to initiate and lead cross-functional projects with both internal and external partners.

• Ability to interface, work effectively, and conduct themselves in the highest professional manner with all levels of the organization, vendors, customers, etc.

• Ability to work in a team environment and adapt to and embrace change in projects, workload, and circumstances effectively; able to respond to new information quickly.

• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.

• Support and comply with the company’s Quality Management System policies and procedures.

• Maintain regular and reliable attendance.

• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.

• Ability and means to travel between work locations.

• Ability to maintain confidential information.

Minimum Qualifications

• Bachelor’s degree in a scientific major or field related to the essential duties of the position.

• 4+ years of professional work experience in quality assurance in a regulated environment.

• 2+ years of direct experience leading process and project implementation, management, or improvement.

• Demonstrated understanding and professional working knowledge of FDA, CLIA, CAP, HIPAA, or other applicable regulatory entities and standards.

• Proficient in Epic healthcare software or other electronic patient medical record (ePHI) software/system.

• Proficient in Microsoft Office programs.

• Demonstrated aptitude for learning new processes and software.

• Demonstrated ability to collaborate across functions with both internal and external stakeholders, and to communicate ideas and opinion in a proactive and professional manner.

• Exceptional written and verbal communication skills, excellent attention to detail and organization skills.

• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Advanced degree in a scientific field related to the essential duties of the position.

• Experience with (or demonstrated understanding of) specific state regulatory requirements for clinical laboratory operations, such as CA, NY, MD, and FL.

• Experience with audits or inspections by regulatory bodies, such as CAP, FDA, and/or NY State Department of Health.

• Additional quality assurance or project management certifications such as Six Sigma or PMP.

• Experience developing and maintaining quality indicators, KPIs, dashboards, or quality performance reporting in a clinical laboratory, healthcare, diagnostic, or regulated environment.

• Strong data analysis and interpretation skills, including identifying trends, emerging risks, recurring issues, and opportunities for continuous improvement.

• Experience investigating nonconformances and adverse quality trends, including root cause analysis, CAPA, and effectiveness monitoring.

• Demonstrated ability to facilitate quality reviews and communicate complex quality data into clear, actionable insights for leadership and cross-functional stakeholders.

• Proven ability to collaborate and lead through influence across functions, driving alignment, accountability, and resolution of quality-related issues.

The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted.]]><