Supervisor, Clinical Lab Quality Assurance

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Position Overview

The Supervisor, Clinical Lab Quality Assurance is responsible for the general supervision and maintenance of the quality management system (QMS) and ensures compliance with all regulatory requirements. The Supervisor, Clinical Lab Quality Assurance will monitor the effectiveness of the QMS, identify and lead continuous improvement opportunities, and will educate Exact Sciences' team members and personnel on applicable procedures and regulations.

Essential Duties

Include, but are not limited to, the following:

• Uphold the laboratory quality management system through the development and maintenance of clinical laboratory policies and procedures while continuously monitoring and maintaining policies and procedures in accordance with federal and state guidelines to ensure the clinical laboratory meets respective standards and regulations, such as CAP, CLIA, New York, California, and Maryland.
• Maintain responsibility for nonconforming event management: review and documentation of nonconforming events; conduct investigations, perform root cause analysis, and develop corrective and preventive actions.
• Oversee the laboratory feedback and complaint process from receipt to closure, including management of escalations and data trending.
• Ensure patient medical records are maintained accurately and securely including the timely fulfilment of patient result requests.
• Work with the privacy office and cross-departmental staff to provide training and awareness of the Health Insurance Portability and Accountability Act (HIPAA), protection of patient data, pertinent regulations and requirements, and relevant quality system policies and procedures.
• Assist in developing laboratory-based metrics to measure efficacy of the QMS and provide visibility for management oversight; ensure QMS robustness through; including, but not limited to, conducting internal audits, investigations, evaluations, process implementation, risk management and evaluating continuous improvement opportunities.
• Project management for assignments including, but not limited to, performing gap analysis, risk management, document control, audits, inspections, and process creation and improvement.
• Provide supervision of clinical lab quality assurance team and be available to other personnel to provide onsite and electronic consultation.
• Supervise staff; including, but not limited to,organize,and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
• Communicategoals clearly to employees to ensure understanding and success in achieving them.
• Motivateandinspireemployees to do their best work through coaching.
• Maintainmorale and support employee engagement initiatives.
• Apply exceptional written and verbal communication skills.
• Apply a strong attention to detail; apply organizational and record-keeping skills.
• Ability to collaborate cross-functionally and with both internal and external stakeholders.
• Apply strong leadership and decision-making skills; ability to communicate ideas, opinions, and counterarguments in a proactive and professional manner.
• 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 act with an inclusion mindset and model these behaviors for the organization.
• Ability and means to travel between Madison locations.

Minimum Qualifications

• Bachelor's Degree in a scientific field related to the essential duties of the position.
• 4+ years of experience in quality assurance (or within a quality management system) in a regulated environment.
• 2+ years of experience working in a regulated environment with demonstrated strong understanding of regulations such as CAP, CLIA, patient privacy, or with FDA regulations.
• Strong, demonstrated aptitude for learning new software.
• 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 or additional certifications in Six Sigma or quality assurance.
• 2+ years of direct or indirect leadership experience
• Experience with or demonstrated understanding of specific state regulatory requirements for clinical laboratory operations to include California, New York, Pennsylvania and/or others.
• Experience with audits or inspections by regulatory bodies such as CAP, NY, and/or the FDA.
• Experience working with process and project implementation, management, or improvement.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

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