Global Quality Assurance Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time

As a seasoned expert in quality assurance, you will play a pivotal role in ensuring our clinical trial supplies are compliant with EU regulations.

The ideal candidate will have a deep understanding of ICH guidelines and GMP/GDP standards. They will also be able to lead high-performing quality teams and work effectively across global, cross-functional environments.

We are looking for someone who can:

  • Manage the certification and batch release process for clinical trial supplies
  • Act as Responsible Person (RP) on the Wholesale Distribution Authorisation (WDA)
  • Support regulatory authority inspections and audits (GMP/GDP) across the global clinical and commercial supply chain
  • Advise cross-functional teams on quality issue management and regulatory compliance
  • Monitor and integrate global regulatory trends to ensure quality systems and operations remain compliant and efficient

To be successful in this role, you will need:

  • Bachelor's degree (or higher) in a scientific, engineering, or related discipline
  • Minimum of 10 years' experience in the pharmaceutical or biopharmaceutical industry
  • Eligibility to act as a Qualified Person (QP) under EU directives on the Manufacturing/Importation Authorisation
  • In-depth knowledge of data integrity principles and clinical supply chain operations

This is an exciting opportunity to join our team and make a meaningful contribution to the success of our organization.

If you are a motivated and results-driven individual with a passion for quality assurance, we encourage you to apply for this role.

Skills Required:

  • Leadership skills
  • Communication skills
  • Problem-solving skills
  • Collaboration skills

Please submit your application through the link below.

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