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Quality Systems Manager

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Dublin
  • Sector: IT
  • Date posted: 27/08/2018
  • Job reference: BBBH15192

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  • Responsible for ensuring that the process for the manufacture of Vaccines and Biologics are in compliance with cGMP and the associated regulatory requirements.
  • Responsible for ensuring that there is an effective Quality Management System is in place.
  • Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers
  • Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.
  • Lead proactive evaluation of site compliance against emerging regulatory trends.
  • Identify and lead major compliance initiatives to improve compliance status and overall operational efficiency of the site.
  • Actively participate and in Plant/Quality committees and works with other site functional groups, such as the EC Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives.
  • Partner with colleagues cross functionally to provide support and advice on day to day basis and on a project, basis including communications, training, project work, audit/inspection duties, investigations, batch work, customer queries etc.; thereby ensuring department is audit/inspection ready.
  • Ensure that quality issues are identified, addressed and resolved before activities commences.
  • Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions.
  • Lead the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete.
  • Be an advocate of continuous improvement in the Quality Management Systems.
  • Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same.
  • Represent the sites Quality Management System during Board of Health and other GMP inspections

Qualifications and Experience:

  • Third Level Degree qualified in a Science/Technical or related discipline.
  • 5 years' experience in a similar role in the Pharmaceutical industry managing teams.
  • Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.
  • Advanced leadership skills including ability to lead across function team and work across boundaries.
  • Communication, decision making, people influencing, and project management skills will be important.
  • Critical to success will be an expert level of knowledge of cGMP and Quality System regulations as they pertain to all aspects of the Carlow site.
  • Your role is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. Where we're inventing for life.

If you are interested in applying for this position please contact Aoife Maher on 01-6455251.

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