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, OpEx, 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.