Manager, Laboratory Supplier Quality

4101 Exact Sciences Labs, LLC; Madison (WI); On-site; USD 99,000 - 199,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

High employer retirement contribution

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Manager, Laboratory Supplier Quality in Madison, WI to lead the supplier quality program across the clinical laboratory enterprise. You will ensure compliance with CLIA, CAP, ISO 15189, and FDA QSR while guiding supplier qualification, governance, risk management, and quality agreements.

The role requires 10+ years in supplier quality and 6+ years in leading cross-functional initiatives, with strong analytical and communication skills.

Qualifications

• Bachelor's degree in a scientific field or related discipline.
• 10+ years in supplier quality, QA, regulatory compliance, or related quality functions in regulated industry.
• 6+ years leading cross-functional teams or enterprise initiatives.
• Experience with supplier qualification, monitoring, auditing, risk management, CAPA programs.
• Experience maintaining Quality Management System procedures.
• Knowledge of CLIA, CAP, ISO 15189, FDA QSR, ISO 13485 and state requirements.

Responsibilities

• Lead the laboratory supplier quality program across clinical labs ensuring regulatory compliance.
• Oversee supplier qualification, approval, governance, risk management, and quality agreements.
• Provide quality oversight of suppliers; lead investigations, audits, CAPAs.
• Identify and mitigate supplier-related risks impacting quality and patient safety.
• Establish supplier quality metrics and drive continuous improvement across sites.
• Support regulatory inspections and enterprise quality initiatives.

Skills

Leadership

Supplier quality

Regulatory compliance

Quality systems

Risk management

Cross-functional teams

Education

Bachelor's degree in a scientific field

Regulatory/compliance certifications (ASQ CQE/CQA etc.)

Job description

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

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

• 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.

Compensation

The base pay for this position is $99,300.00 - $198,700.00. In specific locations, the pay range may vary from the range posted.

Job Family & Details

JOB FAMILY: Operations Quality

DIVISION: ONCO Cancer Diagnostics

LOCATION: United States > Madison : 1 Exact Lane

ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Equal Opportunity

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

About the Company

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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