Quality Systems Manager


  • Company:
    Abbott
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    2 weeks ago
  • Category:
    General

**Abbott Ireland Diagnostic Division – Longford:**

Abbott established a diagnostics manufacturing facility in Sligo in 1994 to manufacture blood-screening products and reagents.

In 2004, Abbott’s operations in Ireland expanded with the opening of a second facility in Longford. The plant was first occupied in December 2004, and the first product (Architect® TSH) was launched in December of 2005.

The Longford facility plays a key role in helping Abbott to meet the increasing global demand for diagnostic testing in areas such as infectious disease, cancer, thyroid and cardiovascular diseases.

Abbott in Longford manufactures 18 diagnostic reagent products for thyroid function, fertility, and pregnancy, cardiology, renal and metabolic. Our products are manufactured to the highest standards of quality and are regulated by bodies such as the U.S. Food and Drug Administration and the International Organization for Standardization (ISO).

We currently have a vacancy for a **Quality Systems Manager** and this role will involve the following:

Primary Function

* Maintenance of the ADD Quality System (QS) to comply with Division, Longford site and applicable external requirements.

Major Responsibilities

* Maintain ETMS TO DO LIST.

* Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well at the Abbott Global and Technical standards.

* Maintain a Quality System in compliance with applicable standards and regulations.

* Maintain an efficient, value-added CAPA / Metrics system.

* Oversee the EMR process from Preparation through to Action planning.

* Maintain an efficient risk management process throughout the site.

* Lead the Quality Systems team. Provide leadership and guidance to reports to ensure both area of work and product quality are maintained to the highest standards.

* Lead Compliance / Audit-readiness activities across the site.

* Promote a culture of “Real-Compliance” across the site through effective communication of metrics and quality KPIs.

* Maintain an efficient record control process per requirements.

* Review and approve changes to Quality System procedures regarding the effect on compliance to applicable standards and regulations.

* Reviews international standards to identify gaps of the Quality System and informs site management about changes that compromise compliance.

* Liaise with Division, Managers & Team Leaders to continuously improve the quality system.

* Communicates with co-workers, other departments and other Abbott sites as needed.

* Set goals and conduct performance reviews on an annual basis for direct reports.

· Monitor and manage QS activities within budget.

Supervisory / Management Responsibility*

This role will involve Supervisory/Management Responsibility.

Education & Experience

* Degree in natural science, Quality Management or comparable education is required to understand the nature of this business.

* Five years of experience in the pharmaceutical or medical device industry or as a Quality professional will provide a good foundation for this job function.

Key Skills

* Excellent communication skills desired. Communicates with coworkers, other departments and other sites.

* Good presentation skills to conduct training and presentations.

* Knowledge of respective standards and regulatory requirements.

Accountability

* Deployed Quality System is in compliance with internal and external requirements.

* Identifies compliance gaps to external and Division requirements and initiates corrective and preventive actions.

* Informs site management on weaknesses of the Quality System and identifies potential improvements.

* Ensures the Quality System is closely aligned with the overall business goals.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com