JOB DESCRIPTION: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 114,000 colleagues serve people in more than 160 countries.

Abbott Ireland Nutrition Division Cootehill Cavan:

Abbott Nutrition produces a range of infant formulae in all pack sizes under the brand name “Similac”. To complement the range of “Similac” infant formulae, the facility also manufactures a range of follow-on formulae under the brand name of “Gain”. The essential ingredient is liquid skim-milk and this is combined with carbohydrate, vegetable oils, vitamins and minerals. The product is blended, pasteurised, dried and packaged at the site and once packaged, is distributed to Europe, South East Asia, the Middle East, Latin America and Canada.

 Established in 1975, Abbott Nutrition in Ireland is the largest powder manufacturing facility for the production of infant formulae within the Abbott Corporation worldwide.  Approximately 1,000 dairy farms in Ireland and Northern Ireland supply quality milk to the Cootehill facility which processes 500,000 litres per day. This secure supply together with Ireland’s reputation as a green, clean environment is of significant strategic importance to Abbott Nutrition.

Please note that this is a fix term contract for 18 months.

Primary Function:

• Adhere to all Environmental, Health and Safety (EHS) rules and regulations within the plant.
• Immediately report any existing or potential hazards to the manager.
• Wear all required Personal Protective Equipment (PPE) appropriate to assigned tasks, including protection from biological and general laboratory hazards. Use appropriate engineering controls such as fume hoods and ventilation as required.
• Review, understand, and follow all Standard Operating Procedures (SOPs) related to assigned tasks.
• Lead by example in following all organisational policies and procedures.

The Quality Operations Manager provides leadership and direction for all plant Quality Assurance systems, including:

• Batch file management & product release
• Documentation control
• Product registration
• Product labelling
• Complaints management

Additional core responsibilities include:

• Supporting and coordinating the internal plant auditing schedule.
• Leading the preparation and execution of external audits, including coordination of plant teams.
• Conducting internal and external audits and monitoring compliance levels.
• Training relevant employees in Quality Systems, including documentation control (“M Files”).
• Reviewing all plant procedures to ensure alignment with company policies and plant expectations.
• Driving clarity and simplicity in SOPs to ensure procedures are understandable and actionable.
• Preparing Gap Analysis Documents for policy or procedural changes and new policy introductions.
• Managing additional Quality Assurance–related projects as required.

This role evolves in accordance with updates to cGMP, EHS, Technical/New Equipment, Quality Procedures, and SOPs. Responsibilities may change based on plant needs; flexibility and adaptability are required.

Major Responsibilities

• Manage and oversee all Quality Systems within the plant, including:

• Batch file management & product release

• Documentation control

• Product registration

• Product labelling

• Complaints management

• Ensure Abbott Cootehill Quality Assurance policies and procedures comply with AQR, Divisional, and market requirements.

• Maintain effective systems to monitor the performance of plant Quality Systems.

Supervisory / Management Responsibilities:

Direct Reports

• Document and Batch Review Co‑ordinator
• Label Development Specialists
• Label Copy Co‑ordinator
• Quality Systems Specialists (Labelling, Complaints Management, Product Registration)

• Additional Leadership Responsibilities
• Regular interaction with all levels of plant management (Manufacturing, Engineering, Quality, Op Ex, Supply Chain/Materials).
• Collaboration with Abbott affiliates, particularly in Quality, Regulatory, Technical, Engineering, Manufacturing, and Materials.
• Liaison with the Abbott Nutrition competent authority in Ireland (DAFM).
• Lead plant managers and SMEs to ensure an effective and robust Quality System.

Education Required

B.Sc. or equivalent degree in a related discipline.

Knowledge & Skills

• Strong understanding of compliance and quality standards.

• Very good knowledge of

• ISO 9001: 2000 and other relevant Quality Certifications.

• Good understanding of applicable EU regulations for Abbott Ireland, Cootehill.

• Strong knowledge of HACCP requirements and programmes.

• Demonstrated leadership capability.

• Strong understanding of plant operations and swabbing locations.

• Excellent interpersonal and communication skills.

Accountability / Scope

The Quality Operations Manager is responsible for ensuring that robust procedures and controls are in place and effectively communicated to all employees to ensure the production of high‑quality products at all times.
Failure to perform this role effectively may result in

product recall and significant business impact.

The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

ANSC Nutrition Supply Chain:

LOCATION:

Ireland > Cootehill : Dromore West

ADDITIONAL LOCATIONS: ##WORK SHIFT:

• Ie
• Chsal39 (Ireland)

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:
Yes

SIGNIFICANT WORK ACTIVITIES:

Not Applicable