Biologics QA Manager

Job description

The Quality Assurance Managers responsible for managing Quality Assurance activities for the Cell Therapy facility. You will work closely with other Quality Department personnel as part of the site Quality Department.

  • Management of the Quality Assurance (Cell Therapy) team, including Qualified Persons.
  • Management of batch record review, batch disposition and material status control activities associated with the Cell Therapy product.  These activities will take place 24/7.
  • Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
  • Management of the Change Control process, ensuring controlled implementation of all GMP related changes.
  • Management of QA oversight of manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
  • The QA Manager will be responsible for implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
  • Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
  • Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
  • The QA Manager will be taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
  • The QA Manager will act as a designee to the Head of Quality for Cell Therapy as required.

The next QA Manager should have a degree in Science or Engineering with at least 6 years experience working in an aspetic environment, you should have at least 3 years experience in a people management position. You should also demonstrate excellent communication and project management skills.

If you're looking to join an innovative company and work within one of the most exciting projects in Ireland currently then send your CV over now!

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.