Manager, Laboratory Supplier Quality

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 122000 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. Youll 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 bachelors 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

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 companys 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

• Bachelors 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.

The base pay for this position is

$99300.00 $198700.00

In specific locations the pay range may vary from the range posted.

Operations Quality

ONCO Cancer Diagnostics

United States > Madison : 1 Exact Lane

Standard

Yes 5 % of the Time

No

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)

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

EEO is the Law link - English: EEO is the Law link - Espanol: Experience:

Manager