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

JOB DESCRIPTION:

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.

The Opportunity
This position works out of our Lake Forest IL location in the Infectious Disease Diagnostics Division. Were 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 Abbotts 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.

What Youll Work On

1. Global QMS Leadership

• 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

2. US Commercial Quality Operations

• 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

3. Commercial Quality Excellence & Transformation

• 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.

Required Qualifications

• Bachelors 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.

Preferred Qualification

• 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

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

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

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Director