Manager, Laboratory Supplier Quality

Position Overview

The Manager, Laboratory Supplier Quality is responsible for ensuring the quality and regulatory compliance of suppliers supporting clinical laboratory operations for Abbott Cancer Diagnostics by providing leadership in the design, implementation, and continuous improvement of laboratory supplier management processes across the laboratory enterprise. The Manager, Laboratory Supplier Quality acts as the primary Laboratory Quality representative within the enterprise supplier management program, providing guidance on laboratory supplier requirements, proactively identifying and mitigating supplier-related risks, and influencing supplier quality strategy to support regulatory compliance, inspection readiness, operational continuity, and scalable laboratory operations. This role is based in our Madison, WI office location.

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

• Lead the laboratory supplier quality program across the clinical laboratory enterprise, ensuring compliance with CLIA, CAP, ISO 15189, company policies, and applicable regulatory requirements.
• Serve as the primary Laboratory Quality representative within the enterprise supplier management program, providing strategic oversight of supplier qualification, approval, governance, risk management, and quality agreements.
• Provide quality and regulatory oversight of suppliers supporting laboratory operations and lead supplier issue management activities, including investigations, corrective actions, audits, assessments, and supplier-related change evaluations.
• Identify, assess, and mitigate supplier-related risks impacting quality, patient safety, regulatory compliance, operational continuity, and inspection readiness.
• Establish and monitor supplier quality metrics, performance indicators, and management review processes while driving standardization, continuous improvement, and long-term supplier performance strategies across laboratory sites.
• Serve as a supplier quality subject matter expert and trusted advisor to leadership, supporting regulatory inspections, accreditation activities, enterprise quality initiatives, and the development of a culture of quality, compliance, and continuous improvement.
• 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 to work designated schedule.
• Ability to work nights and/or weekends, as needed.
• 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 company locations.
• Ability to travel up to 5% of working time away from work location, which may include overnight and weekend travel.

Minimum Qualifications

• Bachelor's Degree in a scientific field, engineering, quality, regulatory affairs, clinical laboratory science, medical technology, or another discipline related to the essential duties of the position.
• 10+ years of experience in supplier quality, quality assurance, regulatory compliance, laboratory operations, or related quality functions within a regulated industry.
• 6+ years of experience leading cross-functional teams, enterprise initiatives, quality programs, or complex projects.
• Demonstrated experience developing, implementing, and managing supplier qualification, supplier monitoring, supplier auditing, supplier risk management, and supplier corrective action programs.
• Demonstrated experience developing, implementing, and maintaining Quality Management System procedures and practices.
• Strong knowledge of applicable regulations and standards affecting laboratory operations and healthcare products, including CLIA, CAP, ISO 15189, FDA Quality System Regulations, ISO 13485, and applicable state requirements.
• Demonstrated ability to lead enterprise-wide quality initiatives, influence quality strategy, and guide leadership in compliance and risk-based decision making.
• Exceptional written, verbal, and interpersonal communication skills.
• Strong analytical, organizational, project management, and problem-solving 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 or Professional certifications in quality, auditing, or compliance (e.g., ASQ CQE, CQA, CMQ/OE, ISO 15189, ISO 13485, or Lead Auditor certification).
• Experience supporting regulatory inspections and accreditation assessments, including CAP, CLIA, FDA, NYSDOH, ISO 15189, or equivalent regulatory frameworks.
• Previous people leadership experience, including coaching, performance management, talent development, and succession planning.
• Demonstrated expertise in supplier governance, supplier performance management, quality metrics, risk management, and oversight of critical suppliers and service providers.
• Knowledge of continuous improvement methodologies, including Lean, Six Sigma, or other operational excellence frameworks.