Lead Clinical Lab QA Specialist

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.
• 3+ years of experience developing, establishing, and implementing quality indicators within a laboratory environment.
• 2+ years of direct experience leading process and project implementation, management, or improvement.
• 2+ years of experience managing, monitoring, and maintaining Quality Management Systems (QMS).
• Demonstrated experience leading quality management meetings with senior leadership, including gathering, analyzing, and presenting key quality metrics, performance indicators, and supporting data to drive discussions and continuous improvement initiatives.
• 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.