Audit Program Manager

Abbott Laboratories A/S; København; On-site; DKK 673,000 - 897,000; Full time

Job summary

Abbott Diagnostics in Ireland seeks an experienced Audit Program Lead to guide internal and supplier audits across global sites, ensuring compliance with GMP and quality systems.

This senior role involves travel up to 65%, leading cross-functional teams, and delivering strategic solutions to complex regulatory challenges. You will drive continuous improvement and support Abbott's commitment to safe, effective healthcare solutions.

Qualifications

• Minimum of 5 years' experience in pharma/medical devices or a highly regulated industry.
• Strong knowledge of GMP, quality systems and regulatory requirements.
• Experience conducting internal, supplier, or external audits.
• Ability to influence stakeholders and drive improvements across functions.

Responsibilities

• Plan, schedule, and conduct internal audits across manufacturing and sites.
• Lead supplier and TPM audits to assess regulatory and quality compliance.
• Maintain audit documentation and deliver findings to leadership.
• Support inspection readiness and global regulatory inspections.

Skills

Internal audits

Supplier audits

Regulatory compliance

Quality systems

CAPA guidance

Audit leadership

Education

Bachelor's degree in Science

Quality management certification

Job description

Audit Program Manager

Placering

Longford

Abbott in Ireland

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.

About Abbott

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.

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.

The Opportunity

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

Internal Audit Leadership

• 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.

Compliance & Continuous Improvement

• 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.

Inspection Readiness

• 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.

Program Management & Reporting

• 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.

Leadership & Influence

• 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.

What You'll Bring

Education

• 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.

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.

Preferred Qualifications

• 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.

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.