Compliance Specialist

This innovative speciality biotech organisation is a leading science-based bio-pharmaceutical company based in the U.S that discovers, invents, develops, manufactures, and commercialises medicines for the treatment of serious medical conditions. This organisation commercialises medicines for eye diseases and rare inflammatory conditions and has product candidates in development in other areas of high unmet medical need. Employing north of 4,000 staff globally with an annual R&D spend of $1 billion, this organisation is consistently being voted one of the top innovative biotech organisations globally.

The Role

This Compliance Specialist position will be responsible for leading compliance related activities, such as investigations, change controls and CAPA’s across all areas. Responsibilities will include:

  • Ensuring that all activities related to the investigation and resolution of non-conformities are performed in a timely manner and in compliance with procedures and regulatory requirements
  • Leading and participating directly in the investigation process
  • Writing and/or reviewing investigation reports
  • Ensuring Corrective & Preventative Actions are appropriate, are implemented as planned, and have the intended effectiveness
  • Identifying recurring events and ensuring appropriate actions are taken, such as management notification
  • Keeping team members informed of the status of assigned work
  • Leading and managing change controls for external manufacturing
  • Working with the team to develop robust training programs

The Person

  • Minimum of an undergraduate degree, ideally an advanced degree (MS or PhD preferred), in related biological and life science field
  • 2 years QA experience within the Pharmaceutical or Biotechnology industry sectors as a minimum requirement
  • Eligible to work and live within the EU

To learn more, apply online or contact Preneta directly on +353 1 6321870 for a confidential discussion.

Salary: On Application Location: Dublin City Centre