Audit Program Manager

About Abbott

Abbott has been a prominent presence in Ireland since 1946, celebrating its 80th anniversary in 2026. The company supports the national healthcare sector with a diversified portfolio that includes diagnostics, diabetes care, medical devices, and nutritional products. Currently, Abbott employs over 6,200 people across ten sites nationwide, including locations such as Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford, and Sligo.

Abbott is a global leader in healthcare, providing life-enhancing technologies across diagnostics, medical devices, nutritionals, and branded generic medicines, with 122,000 employees serving customers in more than 160 countries. Employment offers are contingent on successfully passing a pre-employment medical exam, including drug and alcohol testing conducted by a company-designated medical practitioner.

Role Summary

This role is responsible for overseeing activities related to regulatory compliance within the Internal Audit Program for Abbott Diagnostics. The position plays a crucial role in facilitating and executing internal inspections to identify opportunities for enhancing the Quality System. The individual independently leads audits of suppliers and third-party manufacturers to ensure adherence to applicable external standards, regulations, and Abbott's own Quality System requirements, maintaining standards comparable to regulatory external audits.

Key Responsibilities

• Plan and execute internal audits across Abbott Diagnostic manufacturing and Commercial Affiliate sites to verify compliance with relevant external regulations and Abbott Quality System standards.
• Identify current regulatory compliance risks and assist sites in planning and implementing Quality System improvements.
• Develop and manage internal audit schedules spanning manufacturing, commercial affiliate sites, and supplier/third-party manufacturer audits.
• Monitor regulatory trends to pinpoint compliance risks or areas for Quality System enhancement.
• Conduct audits aligning with standards expected in regulatory external audits.
• Lead initiatives to resolve compliance issues at Commercial Affiliate sites, including CAPA plan development and follow-up guidance to achieve compliance targets.
• Report audit progress within sites and to division leadership as appropriate.
• Provide guidance on inspection readiness across Abbott Diagnostic business sites.
• Conduct topic-specific SIM audits as requested by management.
• Deliver timely audit findings and generate internal audit metrics for site and division management.
• Maintain documentation related to internal and external inspections.
• Act as subject matter expert during audits, offering compliant and strategic solutions for complex quality challenges.
• Lead cross-functional projects, influencing scope and direction, driving new initiatives, and fostering change within and potentially beyond the division.
• Maintain an up-to-date understanding of global standards, regulations, and regulatory bodies. May have managerial duties as required.

Education and Experience

• Bachelor's degree preferred in science or technical fields such as biology, chemistry, engineering, or related disciplines.
• Certification in Medical Technology or Quality Management is advantageous.
• At least five years of experience in pharmaceuticals, medical devices, or other regulated industries.
• Familiarity with Good Manufacturing Practices (GMP), Quality System standards, and regulations such as 21 CFR 820, 21 CFR Part 600, ISO 13485, and the In Vitro Diagnostic Directive (IVDD).
• Auditing training is required; Certified Auditor credentials or equivalent are preferred.