Head of Commercial Quality US, Global QMS and CQ Excellence Lead

Abbott • Lake Forest, CA

11d • Onsite

About The Position

This position works out of our Lake Forest, IL location in the Infectious Disease , Diagnostics Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. We are seeking a Head of Commercial Quality US, Global Quality Management Systems & Commercial Quality Excellence provides strategic leadership across global Quality Management Systems (QMS), U.S. Commercial Quality (CQ) operations, and Strategic Quality Excellence initiatives within our Infectious Disease Rapid Diagnostics (ID RMDx) business. This role is critical in ensuring regulatory compliance, operational excellence, and continuous quality improvement across a global, highly matrixed organization.

Requirements

• Bachelor’s degree in Science, Engineering, Pharmacy, or related field
• 10+ years of experience in Quality Assurance/Compliance within a regulated industry
• 6 years experience in medical device, diagnostics, IVD, or pharmaceutical environments
• Project Management experience (Mid to large scale projects).
• Understanding of Project Management tools and processes.

Nice To Haves

• Strong understanding of QMS, CAPA, audits, and regulatory frameworks
• Demonstrated leadership experience in global, matrixed organizations.
• Strong project/program management expertise
• Proven success driving organizational change and quality transformation
• Experience working across international teams and regulatory environments

Responsibilities

• Provide strategic oversight and governance of the global QMS across commercial quality teams
• Drive implementation, effectiveness, and continuous improvement of quality systems and processes
• Lead audit programs (internal, external, regulatory) and represent the organization in audit governance forums
• Oversee CAPA, documentation control, training systems, and quality metrics/trending
• Provide global leadership for supplier and distributor quality management
• Oversee quality metrics, reporting, and management review processes
• Build and strengthen a global culture of quality and compliance
• Act as management representative for quality and regulatory compliance in the US market
• Ensure execution of quality systems, policies, and regulatory requirements across operations
• Lead product complaint handling, investigations, and field corrective actions
• Oversee post-market surveillance, audits, and quality control of distributed products
• Drive quality culture and continuous compliance improvements across people, processes, and products
• Lead global quality excellence initiatives, strategic projects, and continuous improvement programs
• Drive standardization, rollout, and adoption of quality initiatives
• Manage cross-functional, global projects and audit readiness programs
• Support affiliates with quality compliance, remediation, and regulatory readiness.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior