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

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 115,000 colleagues serve people in more than 160 countries.

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. 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. The Opportunity 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. What You'll 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 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. 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 Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/ Follow 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. Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers. The base pay for this position is $129,300.00 - $258,700.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Operations Quality

DIVISION

ID Infectious Disease

LOCATION

United States >

Lake Forest :

J55 ADDITIONAL LOCATIONS

WORK SHIFT:

Standard TRAVEL:

Yes, 25 % 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) 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 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.

Follow Us:

Facebook LinkedIn YouTube Twitter