JOB DESCRIPTION:
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 5,000 people across nine 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.
Diabetes Care Kilkenny
Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.
At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare.
This is how you can make a difference at Abbott:
As a Quality Compliance Lead you will be responsible for leading a Process or leading a team of Quality professionals. Management of applicable Quality System requirements within the QA functional area, in accordance with corporate, divisional and applicable regulatory requirements.
Key Responsibilities
Implement a work environment that ensures all communication, interpersonal interactions and business activities are consistent with ADC values and the Abbott Code of Conduct.
Maintain an appropriate balance of quality, compliance, and business risk. Provide compliant yet practical solutions that minimise the impact of Quality issues.
Represent ADC to internal/external Auditors and Regulatory bodies on any issue related to the area of responsibility.
Ensure the area of responsibility and processes are audited at all times, and all audits are supported from a resource and information request perspective.
Manage the investigation of non-conformances affecting the area of responsibility and ensure timely and effective corrective action.
Present and inform the status, report metrics, identify trends and potential issues.
Escalate to management any issues pertaining to non-compliance or failure to achieve agree performance targets.
Maintain the quality and compliance of related procedures, work instructions and training materials.
Identify and implement initiatives to enhance the Quality System.
Provide effective communication with other staff and Quality Management to share information and support the attainment of ADC Quality and business objectives.
Ensure quality and compliance within the business and across the Division.
Consult with the QA Management regarding the recruitment of staff, ensuring that staffing levels are maintained, and recruitment activities are scheduled in accordance with departmental requirements.
When requested, accept any responsibilities, and perform any necessary tasks to support the business and other QAC activities.
Maintain a consistent approach to Health and Safety issues within the working environment to reduce hazards and risk.
Prioritize and coordinate resources to ensure department and site objectives are achieved.
Provide divisional level support and guidance as SME for area of responsibility.
Provide effective guidance and build and maintain effective cross functional relationships with all areas of the business.
Qualifications and Experience
Minimum Level NFQ Level 7 Qualification or equivalent experience.
Minimum of 4 years’ experience in a similar position.
Prior experience of development and/or manufacture of regulated products to ensure familiarity with GMP and/or ISO Quality Systems.
What we Offer
Attractive compensation package that includes competitive pay, as well as benefits such as
Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.
Abbott is an equal opportunities employer.
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:
ADC Diabetes Care
LOCATION:
Ireland > Kilkenny : Kilkenny Business and Technology Park
ADDITIONAL LOCATIONS:
WORK SHIFT:
Ie - Shftpre0 (Ireland)
TRAVEL:
Yes, 20 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable