About the role

We are seeking an experienced Internal Audit Program Lead / Senior Quality Auditor to join our Abbott Diagnostics Quality organization.

In this influential global role, you will lead and conduct internal audits across Abbott Diagnostics manufacturing sites, commercial affiliate locations, suppliers, and third-party manufacturers worldwide. You will play a critical role in ensuring compliance with applicable international regulations, industry standards, and Abbott Quality System requirements, while driving continuous improvement and inspection readiness across the business.

Due to the global nature of this position, the role can be based at any Abbott site. This is a highly mobile position requiring significant international travel (up to 65%) to support audits across Abbott Diagnostics manufacturing sites, commercial affiliates, suppliers, and third-party manufacturing locations worldwide.

This position offers a unique opportunity to work with diverse global teams, identify compliance risks, influence quality improvements, and support Abbott's commitment to delivering safe and effective healthcare solutions.

What you'll do

Plan, schedule, and conduct internal audits across Abbott Diagnostics manufacturing and commercial affiliate sites.
Perform supplier and third-party manufacturer (TPM) audits to evaluate compliance with regulatory and quality requirements.
Execute audits to a standard consistent with regulatory authority inspections.
Identify compliance risks and quality system gaps.
Provide guidance and recommendations to support corrective and preventive actions (CAPAs).
Support sites in driving sustainable quality system improvements.
Monitor emerging regulatory trends and assess potential impacts on the business.
Support inspection readiness initiatives across Abbott Diagnostics sites.
Participate as a subject matter expert (SME) during audits and inspections.
Deliver strategic and compliant solutions to complex quality and regulatory issues.
Develop and maintain internal audit schedules.
Generate audit metrics and compliance reports for site and divisional leadership.
Ensure timely communication of audit findings and recommendations.
Maintain audit documentation and records in accordance with regulatory requirements.
Lead cross-functional quality and compliance projects.
Champion new initiatives and drive change across multiple sites and functions.
Collaborate with global stakeholders to strengthen quality systems and compliance performance.

Nice to have

Certified Auditor qualification or equivalent auditing certification.
Experience within the In Vitro Diagnostics (IVD) industry.
Knowledge of medical device software highly desirable
Experience supporting global regulatory inspections and compliance programs.

Education & certifications

You will have:

A Bachelor's Degree in a scientific or technical discipline such as Biology, Chemistry, Engineering, or a related field.

OR

Certification in Medical Technology or Quality Management.

What you'll get

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

How you'll work

Ireland > Longford : Lisnamuck

Ireland > Kilkenny : Kilkenny Business and Technology Park

Ie - Lfdflg17 (Ireland)

Not specified

About the company & team

Abbott has maintained a strong presence in Ireland since 1946 and celebrates its 80th anniversary in the country in 2026. The company supports the Irish healthcare sector with a broad portfolio spanning diagnostics, diabetes care, medical devices and nutritional products. Today, Abbott employs more than 6,200 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

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.

Experience

Minimum of 5 years' experience within the pharmaceutical, medical device, diagnostics, or another highly regulated industry.
Strong understanding of Good Manufacturing Practices (GMP), Quality Systems, and regulatory requirements.
Experience conducting internal, supplier, or external audits.
Demonstrated ability to influence stakeholders and drive quality improvements across multiple functions.

Additional Requirements

Willingness and flexibility to travel internationally up to 65% of the time.
Strong communication, analytical, and problem-solving skills.
Ability to work independently while collaborating effectively with global teams.

JOB FAMILY

Operations Quality

DIVISION

CRLB Core Lab

MEDICAL SURVEILLANCE

Yes

SIGNIFICANT WORK ACTIVITIES

Not Applicable

Additional information

Please note any offer of employment for this position is conditional upon the successful completion of a pre-employment medical examination, including drug and alcohol screening, conducted by a medical practitioner designated by the Company.

Audit Program Manager

Empieza con tu correo