Senior Manager, IRT Development Supply Quality

2 weeks ago

Dublin, Dublin City, Ireland Quality Analytics Full time

This is what you will do:

  • The senior manager for IRT Development Supply Quality will provide quality oversight and support to the Product Development - Clinical Supply (PDCS) IRT team in ensuring adherence to quality standards in the setup, operation, and management of Interactive Response Technology (IRT) systems supporting our clinical studies.
  • This role will play a critical part in the oversight of Alexion's IRT vendors for maintaining the integrity and compliance of clinical supply, data management, and study-specific operations.
  • This position offers an opportunity to contribute significantly to the quality and compliance of our clinical supply operations, ensuring the success of our clinical studies and the safety of our patients.

You will be responsible for:

  • Lead and oversee quality assurance and compliance activities related to the operational use of IRT systems for Alexion clinical studies.
  • Provide support as the initial point of escalation for IRT-related quality issues. Ensure appropriate internal and external escalation pathways are followed and work with the IRT vendor and PDCS IRT team through resolution of issues.
  • Serve as the quality contact for major and critical IRT-related deviations. Review vendor investigation reports, verify that CAPAs are fit for purpose and address root causes with IRT vendor and in collaboration with PDCS IRT team.
  • Support the implementation of IRT standards and best practices, including participation in internal IRT Governance forums and vendor oversight.
  • Own and oversee Quality Agreement management and review with Alexion's IRT vendors.
  • Support audit and regulatory inspection readiness by ensuring appropriate compliance with GCP, GMP, and other regulatory requirements.
  • Maintain oversight and ensure adherence to quality deliverables by Alexion IRT vendors.

You will need to have:

  • Seven years + in a GMP or GCP quality role in the Biopharmaceutical manufacturing industry. Relevant quality experience in supply chain and clinical product support systems including IRT.
  • Understanding of end-to-end IRT systems. Specific experience in issue management and vendor oversight.
  • Ability to work effectively in a cross-functional environment, engaging in computer-based work, problem-solving, complex thought, and collaboration during standard business hours.

We would prefer for you to have:

  • Experience with quality management systems, i.e. Vault

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.


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