Compliance Manager

Have you ever wanted to make a difference?

At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

Abbott Ireland

In Ireland, Abbott employs over 6,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.

Vascular Division Clonmel

Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular Clonmel 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 manufactured in Clonmel includes vessel closure, endovascular and coronary technologies. These devices are designed to treat heart attack, stroke, critical limb ischemia and other serious vascular conditions.

Abbott Vascular Clonmel is the largest Abbott Manufacturing facility in Ireland focusing on both manufacturing and research and development of next generation vascular products.

Purpose Statement:

The Compliance Manager is responsible for maintaining the Clonmel activities as part of the internal audit programme to effectively assess and report on the business unit's compliance status relative to defined quality system requirements. Primary responsibilities include planning activities needed to assess the status of the quality system, organising resources appropriate to execute the identified plan, approving documentation of the assessment results and corrective action taken, and reporting the status results to management. You will also support the quality system by taking action to align activities with corporate compliance objectives, by facilitating inspections with outside regulatory agencies, and by other tasks as assigned by management.

Key Responsibilities:

1. 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.
2. Keeps the organisation's vision and values at the forefront of decision making and action.
3. Builds strategic partnerships to further departmental and organisational objectives.
4. Assists in the creation of quality tools and training materials by understanding the limitations of existing quality tools and training materials and by helping to identify more effective tools and materials.
5. Monitors compliance with company policies and procedures (for example, compliance with Food and Drug Administration (FDA), British Standards Institution (BSI), Equal Employment Opportunity (EEO) regulations, etc.).
6. Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
7. Develops, monitors and appropriately adjusts the annual budget for department(s).
8. Communicates to management the compliance status of the business unit's quality system through the quality systems review meetings.
9. Facilitates inspections of the business unit by outside regulatory agencies, including any required responses.
10. Establishes and maintains effective structures to ensure consistent implementation of the quality system for Abbott Vascular (AV) Clonmel as the site of legal manufacture.

Job Skills and Education:

1. National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline.
2. 6+ years of related work experience or an equivalent combination of education and work experience.
3. Identifies and acts upon trends that can impact the business. Creates and communicates a motivating compelling vision of the future that supports employee engagement. Develops short and long-term strategies and helps align the resources to achieve them.
4. Develops scenario and contingency plans that ensure achievement of results under changing conditions and situations.
5. Creates an environment of experimentation and uses failure as an opportunity to learn and take alternate action.
6. Creates a sustainable infrastructure and environment that enables growth.
7. Displays continuous energy, intensity and persistence to drive the organisation forward.
8. Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment.
9. Provides direction and guidance to exempt specialist and/or supervisory personnel who exercise significant latitude and independence in their assignments.

The base pay for this position is N/A

JOB DESCRIPTION:

Have you ever wanted to make a difference?

At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

Abbott Ireland

In Ireland, Abbott employs over 6,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.

Vascular Division Clonmel

Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular Clonmel 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 manufactured in Clonmel includes vessel closure, endovascular and coronary technologies. These devices are designed to treat heart attack, stroke, critical limb ischemia and other serious vascular conditions.

Abbott Vascular Clonmel is the largest Abbott Manufacturing facility in Ireland focusing on both manufacturing and research and development of next generation vascular products.

Purpose Statement:

The Compliance Manager is responsible for maintaining the Clonmel activities as part of the internal audit programme to effectively assess and report on the business unit's compliance status relative to defined quality system requirements. Primary responsibilities include planning activities needed to assess the status of the quality system, organising resources appropriate to execute the identified plan, approving documentation of the assessment results and corrective action taken, and reporting the status results to management. You will also support the quality system by taking action to align activities with corporate compliance objectives, by facilitating inspections with outside regulatory agencies, and by other tasks as assigned by management.

Key Responsibilities:

1. 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.
2. Keeps the organisation's vision and values at the forefront of decision making and action.
3. Builds strategic partnerships to further departmental and organisational objectives.
4. Assists in the creation of quality tools and training materials by understanding the limitations of existing quality tools and training materials and by helping to identify more effective tools and materials.
5. Monitors compliance with company policies and procedures (for example, compliance with Food and Drug Administration (FDA), British Standards Institution (BSI), Equal Employment Opportunity (EEO) regulations, etc.).
6. Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
7. Develops, monitors and appropriately adjusts the annual budget for department(s).
8. Communicates to management the compliance status of the business unit's quality system through the quality systems review meetings.
9. Facilitates inspections of the business unit by outside regulatory agencies, including any required responses.
10. Establishes and maintains effective structures to ensure consistent implementation of the quality system for Abbott Vascular (AV) Clonmel as the site of legal manufacture.

Job Skills and Education:

1. National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline.
2. 6+ years of related work experience or an equivalent combination of education and work experience.
3. Identifies and acts upon trends that can impact the business. Creates and communicates a motivating compelling vision of the future that supports employee engagement. Develops short and long-term strategies and helps align the resources to achieve them.
4. Develops scenario and contingency plans that ensure achievement of results under changing conditions and situations.
5. Creates an environment of experimentation and uses failure as an opportunity to learn and take alternate action.
6. Creates a sustainable infrastructure and environment that enables growth.
7. Displays continuous energy, intensity and persistence to drive the organisation forward.
8. Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment.
9. Provides direction and guidance to exempt specialist and/or supervisory personnel who exercise significant latitude and independence in their assignments.

The base pay for this position is N/A

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

About Us

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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