Senior Manager, IRT Development Supply Quality

3 weeks ago


Dublin, Dublin City, Ireland Alexion Pharmaceuticals Full time
This is what you will do:
  • The senior manager for IRT Development Supply Quality will provide oversight and support to the Product Development - Clinical Supply (PDCS) IRT team, ensuring adherence to quality standards in the setup, operation, and management of Interactive Response Technology (IRT) systems for our clinical studies.
  • This role will be critical in overseeing Alexion's IRT vendors to maintain integrity and compliance in clinical supply, data management, and study-specific operations.
  • This position offers a valuable opportunity to enhance the quality and compliance of our clinical supply operations, contributing to the success of our studies and the well-being 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, ensuring proper internal and external escalation pathways are followed for issue resolution.
  • Act as the quality contact for significant IRT-related deviations, collaborating with vendors and the PDCS IRT team to address root causes and implement corrective actions.
  • Support the establishment of IRT standards and best practices, including active participation in internal IRT Governance forums and vendor management.
  • Manage Quality Agreements and review processes with Alexion's IRT vendors.
  • Ensure audit and regulatory inspection readiness by maintaining compliance with GCP, GMP, and other regulatory standards.
  • Provide oversight to ensure quality deliverables from Alexion IRT vendors.
You will need to have:
  • Seven years or more experience in a GMP or GCP quality role within the Biopharmaceutical manufacturing sector, with relevant expertise in supply chain and clinical product support systems, including IRT.
  • Familiarity with end-to-end IRT systems, as well as experience in issue management and vendor supervision.
  • Proficiency in working in a cross-functional environment, engaging in computer-based tasks, problem-solving, and collaboration during standard business hours.
We would prefer for you to have:
  • Experience with quality management systems, such as Vault.
Date Posted 24-May-2024Closing Date 20-Jun-2024

Our aim is to foster an inclusive and fair environment. At AstraZeneca and Alexion, we strive for candidates to feel a sense of belonging throughout our recruitment process. We encourage and review applications from all qualified individuals, regardless of personal traits. We provide reasonable adjustments/accommodations to ensure all candidates can perform optimally. Should you require any accommodations, please indicate this in the application form.



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