Audit Program Manager
Abbott · Ireland - Longford ·
- Category
- Project management
- Experience
- 5+ years
- Company size
- 1000+
Manages and conducts internal audits for Abbott’s diagnostic and medical device sites to ensure compliance with regulations like ISO 13485 and 21 CFR 820, driving quality system improvements.
JOB DESCRIPTION:
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.
MAIN PURPOSE OF ROLE
This position administrates regulatory compliance activities related to the Internal Audit Program. The position is key in the facilitation/execution of the internal inspection process and ensures the Internal Audit Program across the Abbott Diagnostic business Sites/Commercial Affiliate Sites serves to identify Quality System improvements. Independently conducts assigned audits of Suppliers and Third Party Manufacturers (TPM's) to assess compliance to all applicable external standards and regulations as well as Abbott Quality System requirements at a standard commensurate with regulatory external audits.
MAIN RESPONSIBILITIES
• Plans and conducts internal audits across the Abbott Diagnostic business Sites/Commercial Affiliate Sites to assess
compliance to all applicable External Standards and Regulations as well as Abbott Quality System requirements.
• Identifies compliance risks to current regulations and guides the sites in the planning and execution of Quality System
improvements.
• Prepares and implements Internal Audit schedules spanning the Abbott Diagnostic business manufacturing sites,
Commercial Affiliate sites, as well as the scheduling and performance of Supplier / TPM audits.
• Uses current regulatory trends to identify potential compliance risks or opportunities for improvement in the Abbott
Diagnostic business Quality System.
• Conducts internal audits at a standard commensurate with regulatory external audits.
• Leads initiatives to address compliance gaps across the Commercial Affiliate Sites. This may include the development of
CAPA plans and resulting follow-up guidance activities in support of the Commercial Affiliates to attain the required level
of compliance.
• Reports progress of audits within Sites and to Division personnel as appropriate.
• Provides guidance to applicable “Inspection-Readiness” activities across the Abbott Diagnostic business Sites.
• Performs topic specific SIM audits at the Abbott Diagnostic business sites as requested by management.
• Reports audit findings in a timely manner.
• Generates and reports internal audit metrics to Site and Division Management.
• Maintains files and documentation associated with internal and external inspections.
• Participates as SME in audits; provides compliant, and strategic solutions to complex quality issues.
• Leads projects that are cross-functional in scope; directly influences project direction and scope; champions new
initiatives and acts as the catalyst for change within and potentially across Divisions. Maintains and demonstrates an
understanding of global standards, regulations and regulatory bodies. May assume managerial responsibilities as needed.
Education
- Bachelors Degree preferably in science or technical discipline such as biology, chemistry, engineering or
- Certification in Medical Technology or Quality Management.
Experience/Background
- Minimum 5 years
- in pharmaceutical or medical device industry or other regulated industry.
- Working knowledge of Good Manufacturing Practices (GMPs), Quality System standards
- and regulatory requirements such as 21 CFR 820, 21 CFR Part 600, ISO 13485, and IVDD etc.
- Trained in auditing techniques; Certified Auditor qualification or equivalent is preferred.
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The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.