Compliance Manager

2 months ago

Clonmel, Ireland Abbott Full time

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:

Compliance Manager is responsible for maintaining the Clonmel activities as part of the internal audit programme to effectively assess and report on the business units 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.Keepstheorganisationsvisionandvaluesattheforefrontof decision making andaction.

3.Buildsstrategicpartnerships tofurtherdepartmentaland organisationalobjectives.

4.Assists in creation of quality tools and training materials by understandingthelimitationsofexisting qualitytoolsandtraining materials and by helping to identify more effective tools and materials.

5.Monitorscompliance withcompany policiesandprocedures(for example (e.g.) compliance with Food and Drug Administration (FDA), British Standards Institution (BSI), Equal Employment Opportunity (EEO) regulations, etcetera(etc.)).

6.Makes decisions regarding work processes or operationalplans and schedules in order to achieve departmentobjectives.

7.Develops, monitors and appropriately adjusts the annual budgetfor department(s).

8.Communicates to management the compliance status of thebusinessunitsqualitysystemthroughthequality systemsreview meetings.

9. Facilitatesinspections ofthebusinessunitbyoutsideregulatoryagencies, including any requiredresponses.

10. Establish and maintain 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.(Experience/Education)NationalFrameworkofQualifications (NFQ) level 7 qualification in a relevantdiscipline.

6+yearsofrelatedworkexperienceoranequivalentcombination of education and workexperience.

2.Set Vision & Strategy: Identifies and acts upon trends that canimpact 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. Translates strategies into actionablegoalsandplans,andthencommunicatesthemtoensure alignment of effort andpurpose.

3.Anticipate: Develops scenario and contingency plans that ensure achievement of results under changing conditions and situations. Takes initiative to implements change before others. Actively gatherscustomerinputsinordertoanticipateandfulfiltheirneeds and requirements. Manages internal/external stakeholdersto

identify and address issues. Understands the situation or audience and adjusts approach to achieve desired outcomes.

4.Innovate: Creates an environment of experimentation and uses failure as an opportunity to learn and take alternate action. Challenges current thinking: generates new ideas and expects otherstodothesame.Integratesinformation frommultiplesources to generate unique insights or new solutions thatdistinguish

Abbottfromthecompetition.Leveragesdiversityofpeopleand thinking to create a competitive advantage. Collaborates across boundaries to create cross-businessopportunities.

5.Build: Creates a sustainable infrastructure and environment that enables growth. Maintains leadership presence and emotional controlindifficultsituations.Providestheinsight,knowledgeand leadership to improve functional are and builds the business. Develops, rewards and shares talent; is the type of leader others want to work with or for. Provides accurate, frequent and constructive feedback to subordinates , peers and leaders. Makes the difficult people, financial and business decisions in a timely manner.

6.Deliver Results: Displays continuous energy, intensity and persistence to drive the organisation forward. Delivers what is promised; holds self and others accountable for results, commitments and behaviours. Takes appropriate accountability for failure; does not blame others. Takes action in a timely manner, with urgency or caution as appropriate, but always in a planned way. Balances short and long-term priorities and maximises the opportunitiesforboth.Addressesorganisationalorculturalbarriers that could preventsuccess.

7. Supervision Received: Work is performed without appreciable direction.Exercisesconsiderablelatitudeindeterminingtechnical

objectives of assignment. Completed work is reviewed from a relatively long-term perspective, for desired results.

8. Supervision Provided: Provides direction and guidance to exempt specialist and/or supervisory personnel who exercise significant latitude and independence in their assignments; evaluates performance of and assists in career development planning for subordinates often responsible for a centralised staff or professional function of the company .

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