Quality Assurance Manager – Regulatory & Quality Lead

Abbott; Clonmel; On-site; EUR 90,000 - 120,000; Full time

Job summary

Abbott Ireland in Clonmel seeks a senior Quality leader to manage Quality Engineering, Supplier Quality, Regulatory Compliance, Analytical Laboratories, Product Release and Quality Control functions in support of Manufacturing and New Product Development.

You will plan and lead the quality organisation to meet FDA, ISO and COP381 requirements, direct major projects to ensure high-quality products, coach subordinates and manage budgets while delivering measurable quality improvements.

Qualifications

• NFQ level 7 qualification and 6+ years relevant work experience.
• Set Vision & Strategy: Identifies and acts upon trends and communicates a motivating vision.
• Anticipate: Develops scenarios and contingencies and manages stakeholders.
• Innovate: Drives new ideas, collaborates cross‑boundary, leverages diversity.
• Build: Creates sustainable infra and develops talent; provides feedback.
• Deliver Results: Maintains accountability and drives timely outcomes.
• Supervision Received/Provided: Operates with leadership guidance and supports juniors.

Responsibilities

• Oversee Quality Engineering, Supplier Quality Engineering, Regulatory Compliance, Analytical Laboratories, Product Release and Quality Control to support Manufacturing, Supplier Development, New Product Development and Quality Systems.
• Plan, develop and manage the quality organisation to meet FDA, ISO requirements and COP381.
• Ensure overall compliance and effectiveness of the quality system with established requirements and quality system regulations.
• Direct projects to ensure manufacture of high-quality products and to facilitate compliance with requirements.
• Evaluate performance of direct reports and support career development; ensure budgets and metrics are managed.

Skills

Set Vision & Strategy

Anticipate

Innovate

Build

Deliver Results

Supervision Received

Supervision Provided

Education

NFQ Level 7 qualification

Job description

Abbott Ireland in Clonmel seeks a senior Quality leader to manage Quality Engineering, Supplier Quality, Regulatory Compliance, Analytical Laboratories, Product Release and Quality Control functions in support of Manufacturing and New Product Development.

You will plan and lead the quality organisation to meet FDA, ISO and COP381 requirements, direct major projects to ensure high-quality products, coach subordinates and manage budgets while delivering measurable quality improvements.