Sr. Lab Quality & Regulatory Specialist

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At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Position Overview

The Lab Quality and Regulatory Specialist is responsible for ensuring regulatory compliance in the clinical laboratory, including leading the QMS program development and continuous improvement opportunities, facilitating and leading the preparation of internal & external audits, and assist in obtaining laboratory licensure approval of new tests. The Lab Quality & Regulatory Specialist will provide regulatory guidance to cross functional teams to address any regulatory issues or risk.

Essential Duties

Include but are not limited to the following:

• Ensure quality management system improvement through process implementation and continuous improvement opportunities based on regulatory risk.
• Develop and maintain harmonized clinical laboratory quality system plans, policies, processes, and procedures in accordance with federal and state guidelines.
• Lead projects, such as gap analysis, audits, inspections, process creation and improvement as needed.
• Provide laboratory regulatory guidance across the clinical laboratory.
• Lead the preparation and facilitation of internal audits and external inspections.
• Continuously monitor policies and procedures to ensure the clinical laboratory meets respective standards and regulations.
• Support regulatory maintenance activities, such as registrations, reporting, and formal communications with regulatory bodies such as CLIA, CAP, FDA, ISO and states with specific requirements, such as NY, CA, MD, AZ, RI, and PA.
• Coordinate regulatory approval and formal communications with regulatory bodies when obtaining new clinical lab test approval or when changes are needed for a new laboratory.
• Assist with laboratory readiness assessment for product additions or enhancements.
• Review and document non-conforming events, performs root cause analysis, and development of corrective and preventive actions.
• Ability to interface, work effectively, and conduct themselves in a professional manner with all levels of the organization, vendors, customers, etc.
• Ability to work in a team environment and adapt to changing workload and circumstances effectively; able to respond to new information quickly.
• Ability to effectively manage multiple projects simultaneously within defined timelines and prioritize when necessary.
• 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 designated schedule.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability and means to travel between Madison locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Bachelor’s degree in a scientific major or related field and 3+ years of experience in quality assurance in a regulated environment; or high school degree/general education diploma with 4+ years of relevant experience working within a quality management system in a regulated environment and 3+ years of experience in quality assurance in a regulated environment.
• Demonstrated understanding of regulatory requirements for clinical laboratory operations and experience working with a regulatory body such as CLIA, CAP, FDA, etc.
• Demonstrated ability to collaborate across functions with both internal and external stakeholders, and to communicate ideas and opinion in a proactive and professional manner.
• Strong aptitude for learning new software programs.
• Exceptional written and verbal communication skills, excellent attention to detail and organization skills.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Direct experience with or demonstrated understanding of specific state regulatory requirements for clinical laboratory operations, such as California, New York, Maryland, or Florida.
• Direct experience with internal or external audits and inspections by regulatory bodies such as CAP, NY, or ISO.
• Direct experience working wi