Quality Manager (Laboratory)

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.

Abbott Ireland Vascular Division Clonmel

Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development and advancing medicine through training and education.

Our broad line of vascular devices-which includes vessel closure, endovascular and coronary technologies-are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels. These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.

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 the Role

Provide management of a functional area that results in the implementation and achievement of vision, mission and functional objectives. This position is primarily responsible for overseeing and directing Analytical laboratories and Quality Control functions, as required, to support Manufacturing, Supplier Development, New Product Development and Quality Systems.

Plans, develops and manages the quality organisation to assure the continuance of qualified and efficient staff to meet Corporate, Food and Drug Administration (FDA), International Organisation for Standardisation (ISO) requirements as well as other regulatory requirements.

Ensures the overall compliance and effectiveness of the laboratories with established requirements and quality system regulations.

Directs projects to ensure the manufacture of high-quality product and to facilitate compliance with requirements.

Evaluates performance of direct reports and supports career development activities. Ensures that program and project objectives are met, budgets are adhered to and metrics are captured and published.

Main Responsibilities

• Recruits, coaches and develops organisational talent.
• Fosters a diverse workplace that enables all employees to contribute to their full potential in pursuit of organisational objectives.
• Creates an entrepreneurial environment that encourages innovation and accountability.
• Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments; may supervise non-exempt employees.
• Keeps the organisation's vision and values at the forefront of decision-making and actions.
• Demonstrates effective change leadership.
• Builds strategic partnerships to further departmental and organisational objectives.
• Develops and executes organisational and operational policies through the application of technical and professional expertise.
• Monitors compliance with company policies, FDA, BSI and other applicable regulatory requirements.
• Makes decisions regarding work processes, operational plans and schedules to achieve department and site objectives.
• Develops, monitors and manages the annual budget for areas of responsibility.
• Approves documents defining the quality system.
• Reviews subcontractors', suppliers' and service providers' quality systems to ensure purchased products fully comply with specified requirements.
• Participates with manufacturing management at all levels in resolving quality and reliability issues.
• Ensures valid test data is used for all regulatory submissions.
• Oversees completion of the Annual Product Review process as required.

Minimum Requirements

• Bachelor's degree (NFQ Level 7 or equivalent) in a relevant scientific, engineering, quality or related discipline.
• Minimum 9 years' experience in a regulated laboratory, pharmaceutical, medical device or quality environment.
• Proven people leadership experience with responsibility for coaching, developing and managing technical teams.
• Strong knowledge of quality systems, regulatory compliance and laboratory operations.
• Experience supporting regulatory submissions and ensuring the integrity of analytical test data.
• Demonstrated experience managing audits, supplier quality activities and quality improvement initiatives.
• Strong stakeholder management skills with the ability to collaborate effectively across Manufacturing, Quality and Regulatory functions.
• Experience managing departmental budgets, operational plans and strategic objectives.

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

JOB FAMILY:
Operations Quality

DIVISION:
AVD Vascular

LOCATION:
Ireland > Clonmel : Cashel Road

ADDITIONAL LOCATIONS:

WORK SHIFT:
Ie - Coreflex (Ireland)

TRAVEL:
Not specified

MEDICAL SURVEILLANCE:
Yes

SIGNIFICANT WORK ACTIVITIES:
Not Applicable