Quality Compliance 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 109,000 colleagues serve people in more than 160 countries.  

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.  

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

Abbott Ireland Diabetes Care Division Donegal  

The Abbott Diabetes Care division based in Donegal Town manufactures FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre system. 

Main Purpose of the role 

The main responsibility of the Site Compliance Lead is to lead Site Audit Readiness at ADC Donegal. 

Main Responsibilities: 

• Manage site audit readiness activities across the site ensuring areas are always audit ready 

• Manage QR’s related to own area ensuring implementation of timely and effective corrective actions 

• Maintain and update the plant Risk Register 

• Represent ADC Donegal to internal/external Auditors and Regulatory bodies on any matter relating to area of responsibility 

• Ensure area of responsibility and processes are always audit ready and all audits are supported from a resource and information request perspective 

• Act as External audit generalist as  

• Lead and coordinate the audit backrooms during external audits. 

• Conduct and own Plant cGMP compliance process 

• Build and maintain effective cross functional relationships with all areas of the business 

• Maintain an appropriate balance of quality, compliance, and business risk. Provide compliant yet practical solutions that minimize the impact of Quality issues 

• Identify and implement initiatives for continuous improvement of the Quality System 

• Ensure effective communication and leadership to management and other staff on compliance issues and site audit preparedness 

• Provide divisional level support and guidance as SME for area of responsibility 

• Ensure approaches to Quality and Compliance are consistently applied within the business and across the Division 

• When requested, accept any responsibilities, and perform any necessary tasks to support the business and other Quality activities 

• Lead a team of Quality Engineers supporting the quality system 

• Make improvements to the quality system to ensure site compliance is strengthened and regulatory requirements are met 

Minimum Requirements 

• Bachelors Degree : BSc/BEng scientific, engineering or related discipline or an equivalent combination of education & work experience 

• 3 years experience in Quality Management Systems & prior experience of the manufacture of regulated products to ensure familiarity with GMP and/or ISO Quality System requirements. 

• Supervisory experience preferred